M. Margaret Kemeny

Survey of oncologists' perceptions of barriers to accrual of older patients with breast carcinoma to clinical trials†

Prior research has documented the under‐representation in clinical trials of older patients with cancer. In part of a larger study to test the magnitude of these barriers to entering eligible older patients with carcinoma of the breast into clinical trials (Cancer and Leukemia Group B [CALGB] trial 9670), barriers to accruing eligible older patients to clinical trials were obtained from the physicians perspective.

Conducting Molecular Epidemiological Research in the Age of HIPAA: A Multi-Institutional Case-Control Study of Breast Cancer in African-American and European-American Women

Breast cancer in African-American (AA) women occurs at an earlier age than in European-American (EA) women and is more likely to have aggressive features associated with poorer prognosis, such as high-grade and negative estrogen receptor (ER) status. The mechanisms underlying these differences are unknown. To address this, we conducted a case-control study to evaluate risk factors for high-grade ER- disease in both AA and EA women. With the onset of the Health Insurance Portability and Accountability Act of 1996, creative measures were needed to adapt case ascertainment and contact procedures to this new environment of patient privacy. In this paper, we report on our approach to establishing a multicenter study of breast cancer in New York and New Jersey, provide preliminary distributions of demographic and pathologic characteristics among case and control participants by race, and contrast participation rates by approaches to case ascertainment, with discussion of strengths and weaknesses.

Randomized Multicenter Phase II Study of Modified Docetaxel, Cisplatin, and Fluorouracil (DCF) Versus DCF Plus Growth Factor Support in Patients With Metastatic Gastric Adenocarcinoma: A Study of the US Gastric Cancer Consortium

PURPOSE Docetaxel, cisplatin, and fluorouracil (DCF) is a standard first-line three-drug chemotherapy regimen for advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma and is associated with significant toxicity. We examined the safety and efficacy of a modified DCF (mDCF) regimen in a randomized multicenter phase II study. PATIENTS AND METHODS Previously untreated patients with metastatic gastric or GEJ adenocarcinoma were randomly assigned to receive either mDCF (fluorouracil 2,000 mg/m2 intravenously [IV] over 48 hours, docetaxel 40 mg/m2 IV on day 1, cisplatin 40 mg/m2 IV on day 3, every 2 weeks) or parent DCF (docetaxel 75 mg/m2, cisplatin 75 mg/m2, and fluorouracil 750 mg/m2 IV over 5 days with granulocyte colony-stimulating factor, every 3 weeks). The study had 90% power to differentiate between 6-month progression-free survival of 26% and 43%, with type I and II error rates of 10% each. An early stopping rule for toxicity was included, defined as grade 3 to 4 adverse event rate > 70% in the first 3 months. RESULTS From November 2006 to June 2010, 85 evaluable patients were enrolled (male, n = 61; female, n = 24; median age, 58 years; Karnofsky performance status, 90%; GEJ, n = 28; gastric, 57). mDCF (n = 54) toxicity rates included 54% grade 3 to 4 toxicity (22% hospitalized) within the first 3 months and 76% grade 3 to 4 toxicity over the course of treatment. The DCF arm (n = 31) closed early because of toxicity, with rates of 71% grade 3 to 4 toxicity (52% hospitalized) within 3 months and 90% grade 3 to 4 toxicity over the course of treatment. Six-month PFS was 63% (95% CI, 48% to 75%) for mDCF and 53% (95% CI, 34% to 69%) for DCF. Median overall survival was improved for mDCF (18.8 v 12.6 months; P = .007). CONCLUSION mDCF is less toxic than parent DCF, even when supported with growth factors, and is associated with improved efficacy. mDCF should be considered a standard first-line option for patients with metastatic gastric or GEJ adenocarcinoma.

Colorectal Cancer Survivors' Needs and Preferences for Survivorship Information

PURPOSE Before developing a survivorship care plan (SCP) that colorectal cancer (CRC) survivors will value, understanding the informational needs of CRC survivors is critical. METHODS We surveyed survivors treated for nonmetastatic CRC at two hospitals in New York about their needs and preferences for survivorship information. Participants completed treatment 6 to 24 months before the interview and had not received an SCP. We evaluated whether survivors knew their treatment history (10 topics), whether they understood ongoing risks (four topics), and their preferences for receiving 16 topics of survivorship information. RESULTS One hundred seventy-five survivors completed the survey. Most survivors remembered information about past treatment (98% to 99% for each treatment). Fewer survivors knew their risks of local recurrence, distant recurrence, or developing a new CRC (69%, 77%, and 40%, respectively). Most participants reported receiving information about their cancer history and ongoing oncology visits (77% to 86% across topics). Across all topics, 93% to 99% of those who reported receiving information found the information useful. A minority of survivors reported they received information about symptoms to report to doctors, returning to work, or financial or legal issues (5% to 48% across topics), but those who did found the information useful (89% to 100% across topics). CONCLUSIONS In the absence of an SCP, CRC survivors still generally understood their cancer history. However, many lacked knowledge of ongoing risks and prevention. Most survivors stated that they found the survivorship information they received useful. SCPs for CRC survivors should focus less on past care and more on helping survivors understand their risks and plan for the future.

Establishing a General Medical Outpatient Clinic for Cancer Survivors in a Public City Hospital Setting

ABSTRACTINTRODUCTIONMany cancer centers and community hospitals are developing novel models of survivorship care. However, few are specifically focused on services for socio-economically disadvantaged cancer survivors.AIMSTo describe a new model of survivorship care serving culturally diverse, urban adult cancer patients and to present findings from a feasibility evaluation.SETTINGAdult cancer patients treated at a public city hospital cancer center.PROGRAM DESCRIPTIONThe clinic provides comprehensive medical and psychosocial services for patients within a public hospital cancer center where they receive their oncology care.PROGRAM EVALUATIONLongitudinal data collected over a 3-year period were used to describe patient demographics, patient needs, and services delivered. Since inception, 410 cancer patients have been served. Demand for services has grown steadily. Hypertension was the most frequent comorbid condition treated. Pain, depression, cardiovascular disease, hyperlipidemia, and bowel dysfunction were the most common post-treatment problems experienced by the patients. Financial counseling was an important patient resource.DISCUSSIONThis new clinical service has been well-integrated into its public urban hospital setting and constitutes an innovative model of health-care delivery for socio-economically challenged, culturally diverse adult cancer survivors.

Examining Intuitive Cancer Risk Perceptions in Haitian-Creole and Spanish-Speaking Populations

Background: There is a developing emphasis on intuition and affect in the illness risk perception process, yet there have been no available strategies to measure these constructs in non-English speakers. This study examined the comprehensibility and acceptability of translations of cancer risk beliefs in Haitian-Creole and Spanish. Method: An established, iterative, team-based translation process was employed. Cognitive interviews (n = 20 in Haitian-Creole speakers; n = 23 in Spanish speakers) were conducted in an inner-city primary care clinic by trained interviewers who were native speakers of each language. Use of an established coding scheme for problematic terms and ambiguous concepts resulted in rewording and dropping items. Results: Most items (90% in the Haitian-Creole version; 87% in the Spanish version) were highly comprehensible. Discussion: This work will allow for further research examining health outcomes associated with risk perceptions across diverse, non-English language subgroups, paving the way for targeted risk communication with these populations.

Sustaining CBPR Partnerships to Address Health Disparities in Times of Economic Instability

In unstable economic environments, CBPR partnerships in underserved communities may face unanticipated obstacles that threaten success and sustainability. This report describes challenges experienced by HealthLink, a CBPR partnership to address cancer disparities in Queens, N.Y., and how HealthLink adapted. Recommendations for designing CBPR partnerships to overcome unexpected challenges are provided.

Promoting Accrual of Older Patients with Cancer to Clinical Trials: An Alliance for Clinical Trials in Oncology Member Survey (A171602)

This article describes a web‐based survey of the Alliance for Clinical Trials in Oncology membership, including physicians, nurses, patient advocates, project managers, statisticians, leadership, and administrative staff. The goal of the survey was to identify new strategies to effect change in accrual for older patients with cancer by eliciting the opinions of a national sample of the oncology clinical research workforce and patient advocates who participate in high‐impact cancer clinical research.

Cancer beliefs and patient activation in a diverse, multilingual primary care sample

Greater patient activation, defined as having the knowledge, skills, and confidence to manage ones health, is associated with cancer control behaviors. Cancer risk beliefs may be associated with patient activation, and delineating this relationship could inform cancer control interventions across diverse patient subgroups. This study examines associations between cancer risk beliefs, language preference, and patient activation within a multilingual urban primary care setting.

How Many Patients and How Many Complications Does It Take to Decide if a Drug Is Safe to Use Before Surgery

TO THE EDITOR: I congratulate Kesmodel et al from The University of Texas M. D. Anderson Cancer Center concerning their recent article in Journal of Clinical Oncology proposing that preoperative bevacizumab does not significantly increase postoperative complications in patients undergoing liver surgery for colorectal cancer metastases. The congratulations are not due to the superiority of their data, but importantly to their self-criticism of the data. The authors concluded that neither the use of bevacizumab nor the timing of bevacizumab administration increases surgical complication rates. However, they qualify their statement by relating that confirmatory prospective studies are required. This is important because in the discussion section of their article, they indeed relate that because their study is retrospective from a single institution with a small number of patients (81 patients in the chemotherapy-plus-bevacizumab group and 44 patients in the chemotherapy-alone group), definitive conclusions about the safety of neoadjuvant bevacizumab and its timing of discontinuation cannot be made. Since the type of chemotherapy, the decision to use bevacizumab, and the duration of chemotherapy and bevacizumab administration, along with the timing of surgical consultation, are at the discretion of the treating physician, the conclusion of their manuscript is preliminary and, as they have stated, must be confirmed prospectively. This group of investigators has a significant experience with hepatic resection of colorectal metastases and continues to recommend waiting at least 6 weeks from discontinuation of bevacizumab before hepatic resection is performed. We certainly can learn from retrospective series, but to the credit of these authors, the self-criticism of their data is laudable. Unfortunately, this is not the case with many retrospective series that appear in the literature, whereupon readers will take the conclusions as definitive. Many of the issues discussed by the authors of this article will be part of the aims of an NCI phase III clinical trial to evaluate neoadjuvant versus adjuvant infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX) plus bevacizumab in patients with potentially resectable hepatic colorectal metastases. The concept of this trial was developed by the Gastrointestinal Leadership of the National Surgical Adjuvant Breast and Bowel Project, American College of Surgeons Oncology Group, and the North Central Cancer Treatment Group. This trial has received approval by the National Cancer Institute Colon Task Force and will soon be presented to the National Cancer Institute Gastrointestinal Steering Committee for discussion. The trial will randomly assign patients with resectable colorectal hepatic metastases to FOLFOX plus bevacizumab before resection followed by the same combination postoperatively versus hepatic resection first followed by postoperative FOLFOX plus bevacizumab. Although the primary end point will be progression-free survival, many secondary end points will be evaluated, including perioperative morbidity related to the agents utilized. I congratulate the authors for discussing the shortcomings of their retrospective review, which should be an example for other authors.