Newswise — CHICAGO – Key studies released today at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) identify new strategies for easing the short- and long-term effects of cancer therapy and improving the quality of life of patients with cancer, as well as their caregivers.

“We've made incredible strides in cancer treatment, and more cancer survivors are alive today than ever before. But oncology isn’t just about helping people live longer – we need to ensure that patients have the best quality of life possible at every stage of their cancer journey, from active treatment through survivorship,” said press briefing moderator Patricia Ganz, MD, FASCO, ASCO Expert and director of Cancer Prevention and Control Research at the Jonsson Comprehensive Cancer Center, University of California, Los Angeles.

“Today’s research reveals new ways of making patients’ lives better, from when we can safely scale back treatment, to a simple new approach for preserving young women’s fertility during cancer treatment. We’re also seeing that earlier use of palliative care enhances the lives of not only patients with advanced cancer, but their caregivers as well,” said Dr. Ganz.

Key studies include: • LHRH analog goserelin helps preserve fertility among women undergoing chemotherapy for hormone receptor-negative breast cancer: New phase III study demonstrates that hormone therapy with goserelin dramatically reduces the risk of chemotherapy-associated premature ovarian failure among women with early-stage hormone receptor-negative breast cancer. Women who received the additional therapy were more likely to conceive following cancer treatment, and even had improved survival.(Related broadcast quality video available for download) • Less frequent (every three month) zoledronic acid is safe, and provides comparable protection against fractures and other skeletal changes in women with breast cancer and bone metastases, compared to the standard monthly treatment: Following a year of standard treatment, less frequent dosing of zoledronic acid had similar side effects without compromising efficacy among women with breast cancer and bone metastases. These findings suggest that less frequent treatments are just as effective for such patients and reduce the burden and cost of treatments. • Lower-dose radiation therapy is safe for certain patients with lower-risk, HPV-positive head and neck cancer: An NIH-funded, phase II study shows that lower-dose IMRT results in 95 percent two-year survival rates among patients with better-prognosis, HPV-positive head and neck cancer. This new approach also spares many patients from debilitating, often life-long side effects of treatment.• Early, phone-based, palliative care support improves caregiver quality of life: A phone-based palliative care intervention helps alleviate caregiver depression and burden, especially if it is offered early after a patient’s diagnosis of cancer. While previous studies have found substantial benefits from palliative care for patients with advanced cancer, this study emphasizes its importance for caregivers as well.• Discontinuing statins near the end of life is safe, improves patient quality of life: For patients with a life-limiting illness, stopping statins in the last year of life improves quality of life without compromising survival. This includes reduced headache, muscle pain and inflammation, drowsiness, and dizziness, as well as substantially reduces the cost of care.Media Resources:• Online Annual Meeting Media Resource Center: Visit for press releases, press briefing recordings, the press briefing schedule at-a-glance, embargo policies, high-resolution photos, print-friendly downloads, and the Virtual Press Room, an online repository of corporate and institutional press releases from third-party organizations. • CancerProgress.Net: The home of ASCO's 50th Anniversary and a timeline detailing the progress made against 18 of the most common cancers. • Cancer.Net: ASCO's cancer information website, providing doctor-approved information on more than 120 cancer types.

The Annual Meeting Media Resource Center will be updated frequently leading up to and throughout the Annual Meeting.

Breast Cancer HER2/ER Oral Abstract Session: Presenting Author: Halle C. F. Moore, MDSaturday, May 31, 2014: 4:24 - 4:36 PM CDT Location: N Hall B1 Cleveland Clinic,Cleveland, OH

LHRH Analog Goserelin Helps Preserve Fertility Among Women Undergoing Chemotherapy for Hormone Receptor-Negative Breast Cancer

New findings from a federally funded phase III clinical trial, S0230/POEMS, indicate that adding a hormone suppressing drug called goserelin to standard chemotherapy may be an effective method of preserving fertility among women with early-stage hormone receptor-negative breast cancer. In the study, women who received goserelin along with chemotherapy were 64 percent less likely to develop premature ovarian failure compared to women who received chemotherapy alone, and they were more likely to have successful pregnancies. Survival was also improved among women in the goserelin arm: women were 50 percent more likely to be alive four years after starting chemotherapy compared to those in the standard arm.

“Preserving fertility is a common and important concern among younger women diagnosed with cancer, and these findings offer a simple, new option for women with breast cancer, or possibly other cancers,” said lead study author Halle Moore, MD, a staff physician at Cleveland Clinic in Cleveland, OH. “Goserelin appears to be not only highly safe but also effective, as it increased the odds of becoming pregnant and delivering a healthy baby following chemotherapy.” Ovarian failure (OF) – defined in this study as cessation of menstrual periods and postmenopausal levels of follicle-stimulating hormone (FSH)– is a common side effect of chemotherapy. OF risk depends on the type and dose of chemotherapy as well as patient age and perhaps ovarian cycling (monthly development of eggs in ovaries) at the time of chemotherapy.

Goserelin and similar luteinizing hormone-releasing hormone (LHRH) analogs temporarily shut down ovarian function, essentially putting the patient into a postmenopausal state. It is speculated that this protects follicles from chemotherapy damage. These medications are widely used to control ovulation timing for infertility procedures, such as in vitro fertilization. LHRH drugs are also widely used as hormonal therapies to treat advanced prostate and breast cancer.

In this study, 257 premenopausal women with stage I-IIIA hormone receptor-negative breast cancer were randomized to treatment with cyclophosphamide-containing chemotherapy alone (standard arm) or chemotherapy plus goserelin. Goserelin was given as monthly injections starting one week before the first dose of chemotherapy.

Two years after starting chemotherapy, 8 percent of women in the goserelin arm had OF vs. 22 percent of women in the standard arm. There was not a statistically significant difference in the number of women who reported attempting to conceive in the two arms. Twenty-one percent of women (22 individuals) assigned to goserelin plus chemotherapy became pregnant, and only 11 percent (12 women) among those assigned to chemotherapy alone became pregnant. These pregnancies resulted in 16 patients (15 percent of the group) delivering at least one baby on the goserelin arm compared with eight patients (7 percent) on the control arm. An additional three patients on the goserelin arm and two on the standard arm had not had a documented delivery but were still pregnant at the time of data submission. The study also found goserelin was safe – it was not associated with an increased risk of either miscarriage or pregnancy termination.

Researchers were surprised to find that goserelin also affected disease-free and overall survival. After adjusting for disease stage, women in the goserelin arm were 50 percent more likely to be alive four years after starting treatment compared to those in the standard arm. While these early results are very encouraging, Dr. Moore cautioned that more research is needed to understand any role of goserelin in the treatment of ER-negative breast cancer. On the other hand, the POEMS findings do establish a role for LHRH analogs in preserving ovarian function and fertility prospects for women treated with curative intent chemotherapy for breast cancer.

This research was supported by the National Institutes of Health.

ASCO Perspective:“Preserving fertility is an important component of quality survivorship care,” said Patricia Ganz, MD, ASCO Expert. “This study provides strong evidence for a safe and effective strategy for younger women with breast cancer to preserve ovarian function and the possibility of pregnancy.”Relevant links from Cancer.Net, the oncologist-approved cancer information website from the American Society of Clinical Oncology:• Guide to Breast Cancer• Fertility Concerns and Preservation for Women• Fertility Preservation

Relevant links from CancerProgress.Net, the home of ASCO's 50th Anniversary and progress made against 18 of the most common cancers:• Progress Against Breast Cancer Timeline

Abstract #LBA505: Phase III trial (Prevention of Early Menopause Study [POEMS]-SWOG S0230) of LHRH analog during chemotherapy (CT) to reduce ovarian failure in early-stage, hormone receptor-negative breast cancer: An international Intergroup trial of SWOG, IBCSG, ECOG, and CALGB (Alliance).

Authors: Halle C. F. Moore, Joseph M. Unger, Kelly-Anne Phillips, Frances M. Boyle, Erika Hitre, David James Porter, Prudence A. Francis, Lori M. Minasian, Richard D. Gelber, Lori J. Goldstein, Henry Leonidas Gomez, Carlos Vallejos, Ann H. Partridge, Shaker R. Dakhil, Silvana Martino, William E. Barlow, Carol J. Fabian, Frank L. Meyskens, Gabriel N. Hortobagyi, Kathy S. Albain; Cleveland Clinic, Cleveland, OH; SWOG Statistical Center, Seattle, WA; Peter MacCallum Cancer Center, Melbourne, Australia; The Mater Hospital, Sydney, Australia; National Institute of Oncology, Budapest, Hungary; Department of Oncology, Auckland City Hospital, Auckland, New Zealand; Peter MacCallum Cancer Centre, East Melbourne, Australia; National Cancer Institute, Bethesda, MD; Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, MA; Fox Chase Cancer Center, Philadelphia, PA; Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru; ONCOSALUD, Lima, Peru; Dana-Farber Cancer Institute, Boston, MA; Wichita Community Clinical Oncology Program, Wichita, KS; The Angeles Clinic and Research Institute, Santa Monica, CA; Cancer Research and Biostatistics, Seattle, WA; University of Kansas Medical Center, Kansas City, KS; Chao Family Comprehensive Cancer Center, Orange, CA; The University of Texas MD Anderson Cancer Center, Houston, TX; Loyola University Medical Center, Maywood, IL

Background: Premature ovarian failure (POF) is a common toxicity of CT. Risk depends on type and amount of CT, age and perhaps ovarian cycling at the time of CT. POEMS is a SWOG-coordinated phase III randomized study to evaluate whether LHRH analog administration with CT for early-stage breast cancer (BC) would reduce POF. Methods: Premenopausal patients (PT) age <50 with stage I-IIIA ER/PR-negative BC to be treated with CT were randomized to receive standard cyclophosphamide-containing CT with or without monthly goserelin (GN) 3.6 mg SQ starting 1 week prior to the first CT dose. The primary endpoint is 2-year POF, defined as amenorrhea for the prior 6 months and post-menopausal FSH. Other endpoints include pregnancies and survival. Endpoints were analyzed in multivariable regression adjusting for stratification factors (age and CT regimen). Results: Between 2/04 and 5/11, 257 PT enrolled. Among 218 evaluable PT, 62% had complete primary endpoint data. Dropouts (n=83) were mostly due to deaths (n=29) or lack of FSH data. There was no strong evidence of informative missing data by arm according to stratification factors (p>.05). POF rates were 22% in the standard arm and 8% in the GN arm (OR=0.30, 95% CI: 0.10-0.87, p=.03 [unadjusted analysis]; OR=0.36, 95%CI: 0.11-1.14, p=0.08 [adjusted logistic regression analysis]). In a sensitivity analysis defining 2-year POF more liberally as either amenorrhea or elevated FSH, 45% in the standard arm and 20% in the GN arm had POF (OR=0.29, 95% CI: 0.12-0.70, p=.006). There were 13 pregnancies in the standard arm and 22 in the GN arm (OR=2.22, 95% CI: 1.00-4.92, p=.05). DFS and OS were better in the GN arm (Cox regression, including stage: HR=0.49, 95% CI: 0.24-0.97, p=.04; HR=0.43, 95% CI: 0.18-1.00, p=.05, respectively). Conclusions: LHRH analog administration with CT was associated with less POF and more pregnancies. In an exploratory analysis, GN use in premenopausal ER-negative BC was associated with improved DFS and OS.

Disclosures: Prudence A. Francis, Other Remuneration from AstraZeneca; Richard D. Gelber, Research Funding from AstraZeneca; Gabriel N. Hortobagyi, Consultant or Advisory Role with AstraZeneca

Research Funding Source: NIH

 Patient and Survivor Care Oral Abstract Session: Monday, June 2, 2014: 3:00 PM - 3:12 PM CDT Presenting Author: Gabriel N. Hortobagyi, MD, FACPLocation: E253 The University of Texas MD Anderson Cancer Center, Houston, TX

Less Frequent Zoledronic Acid Is Safe, and Has Comparable Efficacy for Women With Breast Cancer and Bone Metastases, Compared to the Standard Monthly Treatment

New findings from a phase III randomized study, OPTIMIZE-2, suggest that after a year of monthly treatment with zoledronic acid, women with breast cancer and bone metastasis can safely scale back treatment to an every-three-month schedule. Lower-frequency dosing appeared to have comparable efficacy in reducing complications from bone metastases as monthly dosing, and may decrease the risk of rare, serious side effects associated with zoledronic acid.

“The addition of bisphosphonate drugs like zoledronic acid has dramatically improved the care of patients with bone metastases. But long-term treatment carries the risk of serious side effects, such as osteonecrosis of the jaw and kidney problems,” said lead study author Gabriel N. Hortobagyi, MD, a professor of medicine at the MD Anderson Cancer Center in Houston, TX. “We found that less frequent treatment may reduce the risk of serious side effects, with added benefits in reduced patient inconvenience and cost.”Zoledronic acid is commonly used to reduce complications from bone metastases, such as bone fractures and spinal cord compression. Most doctors give zoledronic acid every four weeks for the first year, starting at diagnosis of bone metastases. It is thought that the treatment should continue indefinitely, but doctors have been concerned about the risk of side effects. To date, there has been limited research, and there are no evidence-based guidelines for the optimal treatment schedule after the first year. In the OPTIMIZE-2 study, 403 women with bone metastases from breast cancer who had completed roughly one year of monthly zoledronic acid therapy were randomly assigned to receive zoledronic acid every month vs. every three months for an additional year. Researchers assessed the skeletal event rate or the proportion of patients with one or more skeletal related events ─ fractures of long bones and vertebrae, spinal cord compressions, and interventions precipitated by bone metastases.

The skeletal event rates were comparable between the two arms (22 percent in the monthly arm vs. 23.2 percent in the every-three-months arm) indicating that less frequent treatment was not inferior to monthly treatment. Other efficacy measures, such as time to first skeletal event and bone turnover markers, were also similar between the two arms. There were no differences in pain levels and use of pain medications between the two treatment schedules. However, due to design limitations and statistical concerns, the efficacy data of OPTIMIZE-2 should be interpreted with caution.

No obvious differences in overall safety profile and in kidney side effects were noted between the two zoledronic acid treatment regimens. Two cases of osteonecrosis of the jaw were reported in the monthly arm, whereas none in the every-three-months treatment arm. Osteonecrosis of the jaw is a condition in which parts of the jawbones weaken and die. The area of necrotic bone is painful and may require surgical removal.

This research was supported by Novartis Pharmaceuticals.

ASCO Perspective:“Women with metastatic breast cancer who require long-term protection against bone fractures now have the option of receiving maintenance bisphosphonate therapy at less frequent intervals without compromising benefit or safety,” said Patricia Ganz, MD, FASCO, ASCO Expert.Relevant links from Cancer.Net, the oncologist-approved cancer information website from the American Society of Clinical Oncology:• Guide to Breast Cancer• ASCO Answers Fact Sheet: When Cancer Spreads to the Bone (PDF)• Bone-Modifying Drugs for Breast Cancer• Dental and Oral Health

Relevant links from CancerProgress.Net, the home of ASCO's 50th Anniversary and progress made against 18 of the most common cancers:• Progress Against Breast Cancer Timeline

Abstract #LBA9500^: Efficacy and safety of continued zoledronic acid every 4 weeks versus every 12 weeks in women with bone metastases from breast cancer: Results of the OPTIMIZE-2 trial.

Authors: Gabriel N. Hortobagyi, Allan Lipton, Helen K. Chew, William John Gradishar, Nicholas P. Sauter, Ramon W. Mohanlal, Ming Zheng, Beth McGrain, Catherine Van Poznak; The University of Texas MD Anderson Cancer Center, Houston, TX; Penn State Hershey Medical Center, Hershey, PA; University of California, Davis, Sacramento, CA; Northwestern University Feinberg School of Medicine, Chicago, IL; Novartis Pharmaceuticals Corporation, East Hanover, NJ; University of Michigan, Ann Arbor, MI

Background: Zoledronic acid (ZOL, 4 mg) every (q) 4 wk reduces the risk of skeletal-related events (SREs) in patients (pts) with bone metastases from breast cancer (BC). The OPTIMIZE-2 trial examined whether ZOL q12 wk was non-inferior to ZOL q4 wk in pts who had previously received monthly IV bisphosphonate (BP) therapy for ~1 year or longer. Methods: This was a prospective, randomized, double-blind, multicenter trial in female pts with bone metastases from BC who previously received ≥9 doses of IV BP (ZOL or pamidronate) during the first 10-15 months of therapy. Pts were randomized (1:1) to receive ZOL 4 mg IV q4 wk or q12 wk (placebo between ZOL doses to maintain blind) for 1 year. The primary endpoint was the proportion of pts with ≥1 SRE on study (SRE rate). Primary analysis was non-inferiority (pre-defined margin of 10%) for the difference in SRE rates. Secondary endpoints included time to first SRE, skeletal morbidity rate (SMR), bone pain score, change in bone turnover markers, and safety. Results: 403 pts were randomized to ZOL q4 wk (n = 200) or q12 wk (n = 203). Median age was 59 years, and baseline characteristics were similar between arms. The SRE rate was 22% and 23.2% in the ZOL q4 and q12 wk arms, respectively. The difference in SRE rate between arms was 1.2% (95% CI, –7.5% to 9.8%; P = .724). The upper limit of this 95% CI (9.8%) is less than the predefined margin of 10%, which indicates non-inferiority of ZOL q12 wk vs q4 wk. Times to first on-study SRE (HR, 1.06; 95% CI, 0.70 to 1.60; P = .792) were similar in the ZOL q4 and q12 wk arms, and mean SMRs were also similar (0.46 vs 0.50, respectively; P = .854). Overall, changes from baseline in bone turnover markers, and the incidence of treatment-emergent adverse events (TEAEs), were similar in the 2 arms. Numerically more renal TEAEs were reported in the ZOL q4 wk vs q12 wk arm (9.6% vs 7.9%, respectively). Two cases (1.0%) of osteonecrosis of the jaw (ONJ) were reported in the q4 wk arm. Conclusions: Among pts who had received monthly IV BP therapy for 1 year or longer, the efficacy of continuing ZOL for an additional year at q12 wk was non-inferior to ZOL q4 wk. Fewer renal AEs and none of the ONJ events were observed in the ZOL q12 wk vs ZOL q4 wk arm.

Disclosures: Gabriel N. Hortobagyi, Consultant or Advisory Role with Novartis, Research Funding from Novartis, Position as an advisory board member and/or consultant of the trial sponsor; Allan Lipton, Honoraria from Novartis, Research Funding from Novartis, Expert Testimony for Novartis; Nicholas P. Sauter, Employment/Leadership Position with Novartis, Stock Ownership with Novartis; Ramon W. Mohanlal, Employment/Leadership Position with Novartis; Ming Zheng, Employment/Leadership Position with Novartis, Stock Ownership with Novartis; Beth McGrain, Employment/Leadership Position with Novartis; Catherine Van Poznak, Consultant or Advisory Role with Novartis, Research Funding from Novartis

Research Funding Source: Novartis Pharmaceuticals

 Head and Neck Cancer Oral Abstract Session: Presenting Author: Anthony Cmelak, MDMonday, June 2, 2014: 9:36 - 9:48 AM CDT Location: E450 Vanderbilt-Ingram Cancer Center, Nashville, TN

Lower-Dose Radiation Therapy Is Safe for Certain Patients With Lower-Risk, HPV-Positive Head and Neck Cancer

– Summary contains updated data, not in the abstract –

A new NIH-funded phase II study suggests that certain patients with human papillomavirus (HPV)-positive oropharyngeal cancer can safely receive lower-dose radiation therapy, using a new approach that customizes radiation dose based on response to induction chemotherapy and other prognostic factors. Lowering the dose of radiation therapy did not compromise outcomes – 95 percent of patients were alive two years after starting treatment.

“Treatment for head and neck cancer can be quite grueling, so it’s very encouraging to see we can safely dial back treatment in patients with less aggressive disease and an overall good prognosis, particularly for young patients who have many years to deal with long-term side effects,” said lead study author Anthony Cmelak, MD, a professor of radiation oncology at the Vanderbilt-Ingram Cancer Center in Nashville, TN. “However, we need longer follow-up, as well as confirmatory phase III data, before we can recommend applying this strategy in practice.”

It is estimated that approximately 70 percent of newly-diagnosed oropharyngeal cancers are related to HPV, and the incidence of HPV-related disease appears to be rising. Patients with HPV-positive tumors tend to have better outcomes compared to patients with HPV-negative disease.

In this first-of-a-kind study, 90 patients with operable stage III/IVA HPV-positive oropharyngeal squamous carcinoma received induction chemotherapy with paclitaxel, cisplatin, and cetuximab. Such therapy sensitizes the cancer to further treatment, and has been shown to decrease the risk of cancer spread, predict the tumor’s sensitivity to radiation, and relieve tumor-related side effects. The 62 patients who had a complete clinical response to induction chemotherapy, meaning they had no signs of cancer on endoscopic exam, received a reduced dose (54 Gy) of intensity-modulated radiation therapy (IMRT), and the rest of the patients received standard dose IMRT (70 Gy). IMRT uses advanced technology to manipulate beams of radiation to conform to the shape of a tumor. All patients received standard cetuximab along with radiation.

The study met its primary endpoint of progression-free survival. Among patients who received lower-dose IMRT, the two-year overall and progression-free survival were 93 percent and 80 percent, respectively; survival was slightly higher among patients with less than 10 pack-years of smoking and earlier-stage disease (two-year progression-free and overall survival were 92 and 97 percent, respectively). As expected, outcomes were worse for the higher-risk patients treated with the standard IMRT dose (two-year overall survival and progression free survival were 87 and 65 percent, respectively). According to Dr. Cmelak, lower-dose IMRT would not be suitable for patients with HPV-negative disease or larger tumors.

Reducing IMRT dose offers patients a better quality of life by decreasing the risk of debilitating, often long-term, side effects ─ trouble swallowing, dry mouth, loss of taste, neck stiffness, and thyroid problems.

Patients will be followed on this study for five years to capture late recurrences. Researchers are also planning another randomized phase II study that will explore an even less intensive approach involving so-called reduced-field IMRT to treat only areas of initial gross tumor in patients with low-risk HPV tumors. It is hoped that this approach would yield similar survival benefits with further reductions in the risk for long-term side effects.

This research was supported by the National Institutes of Health.

ASCO Perspective:“We’ve known for some time that patients with HPV-positive oropharyngeal cancer have a better prognosis than those with non-HPV tumors. This study shows that lowering the dose of radiation may be safe and effective for this group of patients if they respond well to induction chemotherapy,” said Gregory A. Masters, MD, ASCO Expert. “Understanding the biology of cancer allows us to offer more precise therapies for individual patients, and this research offers one more way to provide effective treatment with less toxicity, improving patients’ quality of life.”Relevant links from Cancer.Net, the oncologist-approved cancer information website from the American Society of Clinical Oncology:• Guide to Oral and Oropharyngeal Cancer• What is Radiation Therapy?• Side Effects of Radiation Therapy• HPV and Cancer

Relevant links from CancerProgress.Net, the home of ASCO's 50th Anniversary and progress made against 18 of the most common cancers:• Progress Against Head and Neck Cancer Timeline• Progress in Radiation Therapy Timeline

Abstract #LBA6006: E1308: Reduced-dose IMRT in human papilloma virus (HPV)-associated resectable oropharyngeal squamous carcinomas (OPSCC) after clinical complete response (cCR) to induction chemotherapy (IC).

Authors: Anthony Cmelak, Shuli Li, Shanthi Marur, Weiqiang Zhao, William H. Westra, Christine H. Chung, Maura L. Gillison, Jill Gilbert, Julie E. Bauman, Lynne I. Wagner, Robert L. Ferris, David R. Trevarthen, A. Dimitrios Colevas, Balkrishna N. Jahagirdar, Barbara Burtness; Vanderbilt-Ingram Cancer Center, Nashville, TN; Dana-Farber Cancer Institute, Boston, MA; The Johns Hopkins University School of Medicine, Baltimore, MD; The Ohio State University, Columbus, OH; The James Cancer Hospital and Solove Research Institute, The Ohio State University, Columbus, OH; Vanderbilt University, Nashville, TN; University of Pittsburgh Cancer Institute, Pittsburgh, PA; Feinberg School of Medicine, Northwestern University, Chicago, IL; Department of Otolaryngology, University of Pittsburgh School of Medicine, Pittsburgh, PA; Colorado Cancer Research Program, Denver, CO; Stanford University, Stanford, CA; HealthPartners and Regions Cancer Care Center, St. Paul, MN; Fox Chase Cancer Center, Philadelphia, PA

Background: HPV+ patients (pts) in E2399 obtained a 2-yr 95% survival and 86% PFS after IC and 70Gy chemoradiation. We hypothesized reduced-dose IMRT (54Gy, 23% reduction) in HPV+ OPSCC pts could maintain high LR control and 85% 2-yr PFS in pts with cCR to IC. Methods: Pts with resectable stage III/IVa,b HPV+ OPSCC received IC q3 weeks x 3 with paclitaxel 90mg/m2 days (D) 1,8,15, cisplatin 75mg/m2 D1, and standard cetuximab (Cetux) weekly schedule. IC response determined IMRT dose independently at primary and involved nodes: IMRT 54Gy/27 if cCR vs. 69.3Gy/33 if 10 pkyr (21) 0.71 (0.48, 0.85) 0.90 (0.71, 0.97) Smoker <= 10 pkyr (40) 0.92 (0.81, 0.97) 0.97 (0.87, 0.995) Smoker<=10 pkyr,

Disclosures: Anthony Cmelak, Consultant or Advisory Role with Bristol-Myers Squibb, Honoraria from Bristol-Myers Squibb; Shanthi Marur, Research Funding from Bristol-Myers Squibb; Julie E. Bauman, Consultant or Advisory Role with AVEO, Research Funding from Bristol-Myers Squibb, Novartis, Pfizer, Genentech, and Lilly; Barbara Burtness, Consultant or Advisory Role with Bristol-Myers Squibb, Honoraria from Bristol-Myers Squibb

Research Funding Source: NIH

 Clinical Science Symposium: Palliative Care: Interventions That Matter Tuesday, June 3, 2014: 10:09 AM - 10:21 AM CDT Location: E253 Presenting Author: Marie Bakitas, DNScThe University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, AL Early, Phone-Based, Palliative Care Support Improves Caregiver Quality of Life

Findings from a new study, known as ENABLE III, demonstrate the benefits of a specific palliative care phone-based support program for caregivers of patients with advanced cancer. The findings suggest that the earlier the palliative care services can be introduced to caregivers, the better they will be able to cope with the caregiving experience.

“Family caregivers are a crucial part of the patient care team. Because the well-being of one affects the well-being of the other in a reciprocal way, both parties benefit when caregivers receive palliative care,” said senior study author Marie Bakitas, DNSc, Marie L. O'Koren Endowed Chair and Professor at the University of Alabama School of Nursing in Birmingham, AL. “We found that when caregivers began receiving palliative care support around the time of the patient’s advanced cancer diagnosis, they had less depression, perceived themselves to be less burdened by performing caregiving tasks, and had better quality of life.”

In this federally funded study, one of the first to use a patient and caregiver palliative care intervention in parallel, 207 patients with recurrent or metastatic cancer and 122 family caregivers received palliative care support via a phone-based intervention. One group of patients and family caregivers started receiving this intervention within two weeks of randomization (immediate group) while another group started 12 weeks later (delayed group). The current analysis assessed the benefits only for caregivers.

After enrollment and an in-person assessment, advanced practice palliative care nurses delivered a phone-based curriculum (Charting Your Course) and provided monthly supportive care follow-up to caregivers and patients by telephone. The curriculum covers how to manage problems using creativity, optimism, planning, and expert information; self-care including healthy eating, exercise, and relaxation; how to effectively partner with care recipients in managing symptoms; how to build a support network; and decision-making, decision support, and advance care planning. The Charting Your Course curriculum was developed for the purposes of this research study, and it is publically available. Telephone delivery of the program simplified access to the support for caregivers in rural areas.

Researchers found that the caregivers’ overall quality of life, depression, and demand burden were all improved in the immediate group vs. the delayed group. Early intervention had a large effect on decreasing depression, and small to medium effect on improving quality of life and decreasing perceived burden of caregiving.

“Unfortunately, the full range of palliative care services are rarely taken advantage of because palliative care is often introduced too late in the course of cancer treatment,” said Dr. Bakitas. “Patients and caregivers should understand that palliative care is not end-of-life care but rather an extra layer of support that can be offered along with curative medical treatments.”

Palliative care is focused on providing patients with relief from the symptoms, pain, and stress of a serious illness. By definition, it is a partnership of patient, medical specialists, and family, with the goal of improving quality of life for both the patient and the family.

There are few organized palliative care programs for caregivers of patients with advanced cancer, and reimbursement for this type of counseling is very limited. An online family care navigator tool from the Family Caregiver Alliance’s National Center on Caregiving website may help family givers find assistance in their local area.Patient outcomes from the ENABLE III study will be presented separately at the ASCO Annual Meeting (abstract #9512).

This research was supported by the National Institutes of Health.

ASCO Perspective:“This innovative study demonstrates the need for supporting family caregivers during their loved one’s illness, and the specific benefit of initiating this support sooner than later,” said Patricia Ganz, MD, FASCO, ASCO Expert. “Improving the mental health and well-being of the caregiver is an essential component of good palliative care.”Relevant links from Cancer.Net, the oncologist-approved cancer information website from the American Society of Clinical Oncology:• Caregiver Support• Caring for the Symptoms of Cancer and its Treatment• Advanced Cancer Care Planning• Finding Support and Information

Relevant links from CancerProgress.Net, the home of ASCO's 50th Anniversary and progress made against 18 of the most common cancers:• Progress in Quality of Life Timeline

Abstract #LBA9513: Benefits of immediate versus delayed palliative care to informal family caregivers of persons with advanced cancer: Outcomes from the ENABLE III randomized clinical trial.

Authors: J Nicholas Dionne-Odom, Andres Azuero, Kathleen Lyons, Zhongze Li, Tor Tosteson, Zhigang Li, Jay Hull, Jennifer Frost, Mark Hegel, Konstantin H. Dragnev, Imatullah Akyar, Marie Bakitas; The University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, AL; The Geisel School of Medicine at Dartmouth, Hanover, NH; Norris Cotton Cancer Center, Lebanon, NH; Dartmouth College, Hanover, NH; Dartmouth-Hitchcock Medical Center, Lebanon, NH

Background: Family caregivers of individuals with advanced cancer experience significant burden and diminished QOL; few interventions have been found to reduce these outcomes. Methods: Randomized clinical trial conducted from 10/11/2010 to 9/5/2013 of immediate versus delayed (initiated 12 weeks after randomization) entry patients (n=207) and caregivers (n=122) into ENABLE (Educate, Nurture, Advise, Before Life Ends), a phone-based concurrent oncology palliative care intervention. QOL (Caregiver Quality of Life-Cancer, lower scores=better QOL), depression (Center for Epidemiological Study-Depression) and burden (Montgomery Borgatta Caregiver Burden Scale; subjective burden [SB], objective burden [OB]; demand burden [DB]) measures were collected at baseline, 6, 12, 18, and 24 weeks, and every 12 weeks until patient death or study completion. Results: Estimated treatment effects (immediate minus delayed) for caregivers from randomization to 12 weeks were (mean [SE]): -3.1 [2.3] for QOL (P=.17), -4.1 [1.3] for depression (P=.003), -1.0 [0.4] for SB (P=.02), 0.3 [0.6] for OB (P=.60), and -0.5 [0.6] for DB (P=.39). Estimated treatment effects (immediate minus delayed) from intervention initiation to 12 weeks were (mean [SE]): -6.4 [3.4] for QOL (P=.06), -7.4 [2] for depression (P<.001), -1.0 [0.6] for SB (P=.08), -0.6 [0.7] for OB (P=.44), and -0.5 [0.8] for DB (P=.50). Estimated treatment effects (immediate minus delayed) measured backwards from the time of patient’s death were (mean [SE]): of -4.9 [2.6] for QOL (P=.07), -3.8 [1.5] for depression (P=.02), -1.1 [0.4] for SB (P=.01), -0.6 [0.6] for OB (P=.26), and -0.7 [0.6] for DB (P=.22). Conclusions: Caregivers in the immediate group had lower depression, SB, and trends towards better QOL in comparisons up to 12 weeks, following initiation of the intervention in both groups, and in the terminal decline analysis. These results suggest that concurrent oncology palliative care should be initiated as early as possible to maximize benefit to caregivers.Disclosures: Nothing to disclose

Research Funding Source: NIH

 Clinical Science Symposium: Palliative Care: Interventions That Matter Presenting Author: Amy Pickar Abernethy, MD, PhDTuesday, June 3, 2014: 10:33 - 10:45 AM CDT Location: E253 Duke University Medical Center,Durham, NC

Discontinuing Statins Near the End of Life Is Safe, Improves Patient Quality of Life

New findings from a federally funded randomized study indicate that it is safe to stop statin therapy in patients with a life expectancy of less than a year. Discontinuing statins did not shorten survival, and provided a number of important benefits, including reduced pill and symptom burden and improved overall quality of life.

“Many doctors argue that, near the end of life, it is not necessary to continue medications for chronic illnesses that are not life-threatening. But we have no guidance on what medicines to stop and when to do so,” said lead study author Amy P. Abernethy, MD, PhD, a medical oncologist and palliative care specialist at Duke University Medical Center in Durham, NC. “Our study provides the first evidence that stopping statins is safe and improves patient quality of life.”

The number of medications patients take doubles in the last year of life for those with terminal illnesses. This means patients are taking 10 or more different pills per day – a big burden for patients who frequently have difficulty swallowing and poor appetite. An additional problem is that the side effects of each medication accumulate, and new side effects can appear when multiple drugs are taken together. Furthermore, interactions between drugs can reduce the efficacy of individual treatments.

This study included 381 patients with life-limiting illness (49 percent had cancer) and a life expectancy of one month to one year, who had been taking a statin for at least three months. Statins are cholesterol-lowering drugs prescribed to reduce the risk of heart attacks and strokes. The most common side effects of statins are headache, difficulty sleeping, muscle aches, drowsiness, and dizziness. Patients were randomly assigned to either continue or discontinue statin therapy.

Researchers found that discontinuing statins was safe. Few patients in either group experienced cardiovascular complications (13 in the group that discontinued vs. 11 in the group that continued). The rate of death within 60 days was not significantly different between the two groups (20.3 percent vs. 23.8 percent), and the group that discontinued statins even had a longer median time-to-death (229 days vs. 190 days).

Patients who discontinued statins had a substantially better total quality of life (about a 10 percent improvement on a standard scale) and tended to have fewer symptoms. They also took fewer medications overall compared to patients who continued statins (10.1 vs. 10.8).

Researchers estimate $603 million would potentially be saved in the United States if all people with a life expectancy of a year or less, similar to the group involved in this study, were to discontinue statins. However, Dr. Abernethy noted, discontinuing statins is not appropriate for every patient, and the decision should be made on an individual patient basis.

This research was supported by the National Institute of Nursing Research, National Institutes of Health.

ASCO Perspective:“Discontinuing chronically administered medications near the end of life has limited study. No one wants to ‘rock the boat’ at this stage of life, and continuing medications that have no benefit for prevention of future disease generally makes sense in this situation,” said Patricia Ganz, MD, FASCO, ASCO Expert. “However, now we have evidence that discontinuing certain medications is safe, specifically in the case of the widely prescribed statin drugs, and can improve quality of life for patients.”

Relevant links from Cancer.Net, the oncologist-approved cancer information website from the American Society of Clinical Oncology:• Advanced Cancer Care Planning• Chronic Conditions: When Cancer Is Not Your Only Health Concern• Hospice Care

Relevant links from CancerProgress.Net, the home of ASCO's 50th Anniversary and progress made against 18 of the most common cancers:• Progress in Quality of Life Timeline

Abstract #LBA9514: Managing comorbidities in oncology: A multisite randomized controlled trial of continuing versus discontinuing statins in the setting of life-limiting illness. Authors: Amy Pickar Abernethy, Jean Kutner, Patrick Jud Blatchford, Christine Ritchie, Diane Fairclough, Laura Hanson, Janet Bull, PCRC Investigators; Duke University Medical Center, Durham, NC; University of Colorado Denver, Denver, CO; University of California, San Francisco, San Francisco, CA; The University of North Carolina at Chapel Hill, Chapel Hill, NC; Four Seasons Hospice, Flat Rock, NC Background: For patients with life-threatening illness such as advanced cancer, optimal management of longstanding medications prescribed for comorbid illness is uncertain. Risks may outweigh benefits; e.g., benefits from HMG Co-A reductase inhibitors (“statins”) may take years to accrue and may not be relevant for a person with limited prognosis. Is it safe to discontinue statins for the patient with less than a year to live? Methods: This was a multicenter, unblinded pragmatic trial. At enrollment, participants were randomized (1:1) to discontinue or continue their statin medication. Eligible patients were adults with advanced life-limiting illness on a statin for ≥3 months for primary or secondary prevention, a life expectancy of greater than one month, and evidence of recent deterioration in performance status. Outcomes measured at baseline and at least monthly included survival, cardiovascular-related events, quality of life (QOL), symptoms, and polypharmacy. Rate of death within 60 days of randomization was the primary outcome. Results: 381 patients were enrolled (189 discontinue statins; 192 continue statins). Mean age was 74 years (SD 12); 22% were cognitively impaired; 49% had cancer as the primary diagnosis; and, 69% had used statins for >5 years. Rate of death within 60 days was not statistically different between groups (discontinue vs. continue, 23.8% vs. 20.3%, 90% CI 3.5% to 10.5%, p=0.36). The group discontinuing statins had longer median time-to-death (229 days [90% CI 186–332] vs. 190 days [90% CI 170-257]; p=0.60). Total QOL was significantly better among the group discontinuing statins (McGill QOL: 7.11 vs. 6.85, p=0.037) and there were fewer symptoms in this group (Edmonton Symptom Assessment Scale: 25.2 vs. 27.4, p=0.128). People in the discontinue statins group took significantly fewer medications (10.1 vs. 10.8, p = 0.034). Few participants in either group experienced cardiovascular events (13 vs. 11). Conclusions: In the setting of life-limiting illness such as advanced cancer, it is unlikely that harm will accrue when statins being used for primary or secondary prevention are discontinued; these patients may even benefit.Disclosures: Nothing to disclose

Research Funding Source: NIH


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50th Annual Meeting of the American Society of Clinical Oncology