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Alliance for Clinical Trials in Oncology

Mehra Golshan, Constance T Cirrincione, William M Sikov, Lisa A Carey, Donald A Berry, Beth Overmoyer, Nora L Henry, George Somlo, Elisa Port, Harold J Burstein, Clifford Hudis, Eric Winer, David W Ollila
OBJECTIVE: It had been previously shown that patients who receive neoadjuvant systemic therapy (NST) are more likely to undergo breast-conserving therapy (BCT) than those who have primary surgery. However, the frequency with which patients who are not BCT-eligible prior to NST convert to BCT-eligible with treatment is unknown. To document this conversion rate in a subset of patients expected to have a high clinical response rate to NST, we studied surgical assessment and management of patients enrolled on a randomized neoadjuvant trial for stage II-III HER2-positive breast cancer (HER2 + BC)(CALGB 40601)...
November 2016: Breast Cancer Research and Treatment
Chaitra S Ujjani, Sin-Ho Jung, Brandelyn Pitcher, Peter Martin, Steven I Park, Kristie A Blum, Sonali M Smith, Myron Czuczman, Matthew S Davids, Ellis Levine, Lionel D Lewis, Scott E Smith, Nancy L Bartlett, John P Leonard, Bruce D Cheson
Chemoimmunotherapy in follicular lymphoma is associated with significant toxicity. Targeted therapies are being investigated as potentially more efficacious and tolerable alternatives for this multiply-relapsing disease. Based on promising activity with rituximab and lenalidomide in previously untreated follicular lymphoma (ORR 90-96%) and ibrutinib in relapsed disease (ORR 30-55%), the Alliance for Clinical Trials in Oncology conducted a phase I trial of rituximab, lenalidomide, and ibrutinib. Previously untreated patients with follicular lymphoma received rituximab 375 mg/m(2) on Day 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycle 4, 6, 8, 10, lenalidomide as per cohort dose on Days 1-21/28 for 18 cycles, and ibrutinib as per cohort dose daily until progression...
October 3, 2016: Blood
M A Dickson, M R Mahoney, W D Tap, S P D'Angelo, M L Keohan, B A Van Tine, M Agulnik, L E Horvath, J S Nair, G K Schwartz
BACKGROUND: Aurora kinase A (AURKA) is commonly overexpressed in sarcoma. The inhibition of AURKA by shRNA or by a specific AURKA inhibitor blocks in vitro proliferation of multiple sarcoma subtypes. MLN8237 (alisertib) is a novel oral adenosine triphosphate-competitive AURKA inhibitor. PATIENTS AND METHODS: This Cancer Therapy Evaluation Program-sponsored phase II study of alisertib was conducted through the Alliance for Clinical Trials in Oncology (A091102). Patients were enrolled into histology-defined cohorts: (i) liposarcoma, (ii) leiomyosarcoma, (iii) undifferentiated sarcoma, (iv) malignant peripheral nerve sheath tumor, or (v) other...
October 2016: Annals of Oncology: Official Journal of the European Society for Medical Oncology
Ace J Hatch, Alexander B Sibley, Mark D Starr, J Chris Brady, Chen Jiang, Jingquan Jia, Daniel L Bowers, Herbert Pang, Kouros Owzar, Donna Niedzwiecki, Federico Innocenti, Alan P Venook, Herbert I Hurwitz, Andrew B Nixon
Circulating protein markers were assessed in patients with colorectal cancer (CRC) treated with cetuximab in CALGB 80203 to identify prognostic and predictive biomarkers. Patients with locally advanced or metastatic CRC received FOLFOX or FOLFIRI chemotherapy (chemo) or chemo in combination with cetuximab. Baseline plasma samples from 152 patients were analyzed for six candidate markers [epidermal growth factor (EGF), heparin-binding EGF (HBEGF), epidermal growth factor receptor (EGFR), HER2, HER3, and CD73]...
September 2016: Cancer Medicine
Pamela J Atherton, Kelli N Burger, Levi D Pederson, Suneetha Kaggal, Jeff A Sloan
BACKGROUND/AIMS: The use of patient-reported outcomes in clinical trials is a focal point for research and policy. Non-compliance with planned questionnaires and missing data can threaten both internal validity and generalizability. This retrospective analysis was conducted to determine the extent of, and characteristics associated with, missing patient-reported outcomes. METHODS: Study characteristics, patient characteristics and adverse events, and reasons for non-compliance were compiled from 14 closed Alliance for Clinical Trials in Oncology, Mayo Clinic Cancer Center, or Mayo Clinic Cancer Research Consortium clinical trials...
June 30, 2016: Clinical Trials: Journal of the Society for Clinical Trials
Robert C Miller, Daniel G Petereit, Jeff A Sloan, Heshan Liu, James A Martenson, James D Bearden, Ronald Sapiente, Grant R Seeger, Rex B Mowat, Ben Liem, Matthew J Iott, Charles L Loprinzi
PURPOSE: To provide confirmatory evidence on the use of sulfasalazine to reduce enteritis during pelvic radiation therapy (RT), following 2 prior single-institution trials suggestive that benefit existed. METHODS AND MATERIALS: A multi-institution, randomized, double-blind, placebo-controlled phase 3 trial was designed to assess the efficacy of sulfasalazine versus placebo in the treatment of RT-related enteritis during RT including the posterior pelvis (45.0-53...
July 15, 2016: International Journal of Radiation Oncology, Biology, Physics
Matthew H G Katz, Qian Shi, Syed A Ahmad, Joseph M Herman, Robert de W Marsh, Eric Collisson, Lawrence Schwartz, Wendy Frankel, Robert Martin, William Conway, Mark Truty, Hedy Kindler, Andrew M Lowy, Tanios Bekaii-Saab, Philip Philip, Mark Talamonti, Dana Cardin, Noelle LoConte, Perry Shen, John P Hoffman, Alan P Venook
IMPORTANCE: Although consensus statements support the preoperative treatment of borderline resectable pancreatic cancer, no prospective, quality-controlled, multicenter studies of this strategy have been conducted. Existing studies are retrospective and confounded by heterogeneity in patients studied, therapeutic algorithms used, and outcomes reported. OBJECTIVE: To determine the feasibility of conducting studies of multimodality therapy for borderline resectable pancreatic cancer in the cooperative group setting...
August 17, 2016: JAMA Surgery
Keith L Knutson, Raphael Clynes, Barath Shreeder, Patrick Yeramian, Kathleen P Kemp, Karla Ballman, Kathleen S Tenner, Courtney L Erskine, Nadine Norton, Donald Northfelt, Winston Tan, Carmen Calfa, Mark Pegram, Elizabeth A Mittendorf, Edith A Perez
The addition of trastuzumab to chemotherapy extends survival among patients with HER2(+) breast cancer. Prior work showed that trastuzumab and chemotherapy augments HER2 extracellular domain (ECD)-specific antibodies. The current study investigated whether combination therapy induced immune responses beyond HER2-ECD and, importantly, whether those immune responses were associated with survival. Pretreatment and posttreatment sera were obtained from 48 women with metastatic HER2(+) breast cancer on NCCTG (now Alliance for Clinical Trials in Oncology) studies, N0337 and N983252...
July 1, 2016: Cancer Research
Gita Thanarajasingam, Pamela J Atherton, Paul J Novotny, Charles L Loprinzi, Jeff A Sloan, Axel Grothey
BACKGROUND: Traditional methods of reporting adverse events in clinical trials are inadequate for modern cancer treatments with chronic administration. Conventional analysis and display of maximum grade adverse events do not capture toxicity profiles that evolve over time or longer lasting, lower grade toxic effects; we aimed to address this shortcoming in this study. METHODS: We developed an analytic approach and standardised, comprehensive format, the Toxicity over Time (ToxT) approach, which combines graphs and adverse event tabular displays with multiple longitudinal statistical techniques into a readily applicable method to study toxic effects...
May 2016: Lancet Oncology
Oliver W Press, Hongli Li, Heiko Schöder, David J Straus, Craig H Moskowitz, Michael LeBlanc, Lisa M Rimsza, Nancy L Bartlett, Andrew M Evens, Erik S Mittra, Ann S LaCasce, John W Sweetenham, Paul M Barr, Michelle A Fanale, Michael V Knopp, Ariela Noy, Eric D Hsi, James R Cook, Mary Jo Lechowicz, Randy D Gascoyne, John P Leonard, Brad S Kahl, Bruce D Cheson, Richard I Fisher, Jonathan W Friedberg
PURPOSE: Four US National Clinical Trials Network components (Southwest Oncology Group, Cancer and Leukemia Group B/Alliance, Eastern Cooperative Oncology Group, and the AIDS Malignancy Consortium) conducted a phase II Intergroup clinical trial that used early interim fluorodeoxyglucose positron emission tomography (FDG-PET) imaging to determine the utility of response-adapted therapy for stage III to IV classic Hodgkin lymphoma. PATIENTS AND METHODS: The Southwest Oncology Group S0816 (Fludeoxyglucose F 18-PET/CT Imaging and Combination Chemotherapy With or Without Additional Chemotherapy and G-CSF in Treating Patients With Stage III or Stage IV Hodgkin Lymphoma) trial enrolled 358 HIV-negative patients between July 1, 2009, and December 2, 2012...
June 10, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
Amanda I Phipps, Qian Shi, Paul J Limburg, Garth D Nelson, Daniel J Sargent, Frank A Sinicrope, Emily Chan, Sharlene Gill, Richard M Goldberg, Morton Kahlenberg, Suresh Nair, Anthony F Shields, Polly A Newcomb, Steven R Alberts
Alcohol consumption is associated with a modest increased risk of colon cancer, but its relationship with colon cancer survival has not been elucidated. Using data from a phase III randomized adjuvant trial, we assessed the association of alcohol consumption with colon cancer outcomes. Patients completed a risk factor questionnaire before randomization to FOLFOX or FOLFOX + cetuximab (N = 1984). Information was collected on lifestyle factors, including smoking, physical activity and consumption of different types of alcohol...
September 1, 2016: International Journal of Cancer. Journal International du Cancer
Hyung L Kim, Susan Halabi, Ping Li, Greg Mayhew, Jeff Simko, Andrew B Nixon, Eric J Small, Brian Rini, Michael J Morris, Mary-Ellen Taplin, Daniel George
BACKGROUND: Prognosis associated with metastatic renal cell carcinoma (mRCC) can vary widely. METHODS: This study used pretreatment nephrectomy specimens from a randomized phase III trial. Expression levels of candidate genes were determined from archival tumors using the OpenArray® platform for TaqMan® RT-qPCR. The dataset was randomly divided at 2:1 ratio into training (n = 221) and testing (n = 103) sets to develop a multigene prognostic signature. FINDINGS: Gene expressions were measured in 324 patients...
November 2015: EBioMedicine
Bruce G Haffty, Linda M McCall, Karla V Ballman, Sarah McLaughlin, Reshma Jagsi, David W Ollila, Kelly K Hunt, Thomas A Buchholz, Judy C Boughey
PURPOSE: American College of Surgeons Oncology Group Z1071 was a prospective trial evaluating the false negative rate of sentinel lymph node (SLN) surgery after neoadjuvant chemotherapy (NAC) in breast cancer patients with initial node-positive disease. Radiation therapy (RT) decisions were made at the discretion of treating physicians, providing an opportunity to evaluate variability in practice patterns following NAC. METHODS AND MATERIALS: Of 756 patients enrolled from July 2009 to June 2011, 685 met all eligibility requirements...
March 1, 2016: International Journal of Radiation Oncology, Biology, Physics
Judy C Boughey, Karla V Ballman, Huong T Le-Petross, Linda M McCall, Elizabeth A Mittendorf, Gretchen M Ahrendt, Lee G Wilke, Bret Taback, Eric C Feliberti, Kelly K Hunt
BACKGROUND: The American College of Surgeons Oncology Group Z1071 trial reported a false-negative rate (FNR) of 12.6% with sentinel lymph node (SLN) surgery after neoadjuvant chemotherapy in women presenting with node-positive breast cancer. One proposed method to decrease the FNR is clip placement in the positive node at initial diagnosis with confirmation of clipped node resection at surgery. METHODS: Z1071 was a multi-institutional trial wherein women with clinical T0-T4,N1-N2,M0 breast cancer underwent SLN surgery and axillary dissection (ALND) after neoadjuvant chemotherapy...
April 2016: Annals of Surgery
E M L Smith, H Pang, C Ye, C Cirrincione, S Fleishman, E D Paskett, T Ahles, L R Bressler, N Le-Lindqwister, C E Fadul, C Loprinzi, C L Shapiro
Duloxetine is an effective treatment for oxaliplatin-induced painful chemotherapy-induced peripheral neuropathy (CIPN). However, predictors of duloxetine response have not been adequately explored. The objective of this secondary and exploratory analysis was to identify predictors of duloxetine response in patients with painful oxaliplatin-induced CIPN. Patients (N = 106) with oxaliplatin-induced painful CIPN were randomised to receive duloxetine or placebo. Eligible patients had chronic CIPN pain and an average neuropathic pain score ≥4/10...
November 25, 2015: European Journal of Cancer Care
Kathrine G Nissen
OBJECTIVE: The formation of a strong bond between patients and therapists can lead to successful treatment outcomes. Yet, little is known about the mechanisms that function to control this relationship. The objective of this case report was to examine the ruptures and repairs in the working alliance between a young therapist and an elderly caregiver, and to suggest ways in which to deal with age-related challenges to such an alliance. METHOD: In order to examine the ruptures and repairs in a working alliance, this case report reflects on the interdependent relationship among therapist variables, patient variables, and the therapeutic alliance...
October 2016: Palliative & Supportive Care
Paolo De Paoli, Gennaro Ciliberto, Manlio Ferrarini, PierGiuseppe Pelicci, Paolo Dellabona, Francesco De Lorenzo, Alberto Mantovani, Pellegrino Musto, Giuseppe Opocher, Piero Picci, Walter Ricciardi, Ruggero De Maria
Alliance Against Cancer (ACC) was established in Rome in 2002 as a consortium of six Italian comprehensive cancer centers (Founders). The aims of ACC were to promote a network among Italian oncologic institutions in order to develop specific, advanced projects in clinical and translational research. During the following years, many additional full and associate members joined ACC, that presently includes the National Institute of Health, 17 research-oriented hospitals, scientific and patient organizations. Furthermore, in the last three years ACC underwent a reorganization process that redesigned the structure, governance and major activities...
2015: Journal of Translational Medicine
Steven M Devine, Kouros Owzar, William Blum, Flora Mulkey, Richard M Stone, Jack W Hsu, Richard E Champlin, Yi-Bin Chen, Ravi Vij, James Slack, Robert J Soiffer, Richard A Larson, Thomas C Shea, Vera Hars, Alexander B Sibley, Sergio Giralt, Shelly Carter, Mary M Horowitz, Charles Linker, Edwin P Alyea
PURPOSE: Long-term survival rates for older patients with newly diagnosed acute myeloid leukemia (AML) are extremely low. Previous observational studies suggest that allogeneic hematopoietic stem-cell transplantation (HSCT) may improve overall survival (OS) because of lower rates of relapse. We sought to prospectively determine the value of HSCT for older patients with AML in first complete remission. PATIENTS AND METHODS: We conducted a prospective multicenter phase II study to assess the efficacy of reduced-intensity conditioning HSCT for patients between the ages of 60 and 74 years with AML in first complete remission...
December 10, 2015: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
Heshan Liu, Angelina D Tan, Rui Qin, Daniel J Sargent, Axel Grothey, Jan C Buckner, Paul L Schaefer, Jeff A Sloan
INTRODUCTION: Current standard evaluation of Peripheral Neuropathy (PN) is based on an investigator-reported classification system that is commonly unable to correctly reflect the subjective symptoms for patients. Thus more reliable methods to assess PN are needed. This study assessed alternative methods of assessing patient-reported PN in 5 North Central Cancer Treatment Group (NCCTG) clinical trials. METHOD: Two single-item assessments relating to numbness and tingling were used to measure PN...
2015: SOJ Anesthesiology & Pain Management
Vera Jean Suman, Matthew J Ellis, Cynthia X Ma
The Alliance for Clinical Trials in Oncology cooperative group has designed a phase III neoadjuvant clinical trial (ALTERNATE trial) which randomizes women with cT2-4 N0-3 M0 ER+/Her2- invasive breast cancer to either anastrozole, fulvestrant or its combination to assess a biomarker-driven treatment strategy to identify women with a low risk of disease recurrence. This strategy incorporates the findings that: higher expression of the proliferation marker, Ki67, after 2 weeks of neoadjuvant endocrine therapy (ET), is associated with poor recurrence-free survival, and that patients with surgical findings of pT1/2, pN0 disease, Ki67 ≤2...
September 2015: Chinese Clinical Oncology
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