Northern Indiana Cancer Research Consortium

South Bend, IN, United States

Northern Indiana Cancer Research Consortium

South Bend, IN, United States
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Background: Concurrent chemoradiation with etoposide and cisplatin (EP/XRT) is standard treatment for inoperable stage III locally advanced non-small-cell lung cancer (LA-NSCLC). Consolidation docetaxel (D; Taxotere) after EP/XRT resulted in increased toxicity but no improvement in survival compared with observation (O). We report updated survival for the entire study population and include an analysis of efficacy and tolerability of EP/XRT with or without D in patients aged ≥ 70 years. Patients and methods: Hoosier Oncology Group LUN 01-24 enrolled 243 patients with LA-NSCLC and randomized 166 after EP/XRT to three cycles of D versus O. the trial was terminated after an analysis of the first 203 patients demonstrated futility of D. Results: Median survival time (MST) for the overall study population was 21.5 months, and 3-, 4-, and 5-year survival rates were 30.7%, 18.0%, and 13.9%, respectively. No differences in MST or 3-year survival were noted between D and O arms. Older patients had similar MST (17.1 versus 22.8 months for younger patients, P = 0.15) but higher rates of grade 3/4 toxicity and hospitalization during induction. Conclusions: Consolidation docetaxel after EP/XRT does not improve survival in LA-NSCLC. Fit older adults with LA-NSCLC benefit from concurrent chemoradiation similarly as younger patients but experience higher rates of hospitalization and toxicity. © the Author 2011. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.

Whitworth P.,Nashville Breast Center | Stork-Sloots L.,Agendia Inc. | de Snoo F.A.,Agendia Inc. | Richards P.,Blue Ridge | And 10 more authors.
Annals of Surgical Oncology | Year: 2014

Purpose: The purpose of the NBRST study is to compare a multigene classifier to conventional immunohistochemistry (IHC)/fluorescence in situ hybridization (FISH) subtyping to predict chemosensitivity as defined by pathological complete response (pCR) or endocrine sensitivity as defined by partial response. Methods: The study includes women with histologically proven breast cancer, who will receive neoadjuvant chemotherapy (NCT) or neoadjuvant endocrine therapy. BluePrint in combination with MammaPrint classifies patients into four molecular subgroups: Luminal A, Luminal B, HER2, and Basal. Results: A total of 426 patients had definitive surgery. Thirty-seven of 211 (18 %) IHC/FISH hormone receptor (HR)+/HER2− patients were reclassified by Blueprint as Basal (n = 35) or HER2 (n = 2). Fifty-three of 123 (43 %) IHC/FISH HER2+ patients were reclassified as Luminal (n = 36) or Basal (n = 17). Four of 92 (4 %) IHC/FISH triple-negative (TN) patients were reclassified as Luminal (n = 2) or HER2 (n = 2). NCT pCR rates were 2 % in Luminal A and 7 % Luminal B patients versus 10 % pCR in IHC/FISH HR+/HER2− patients. The NCT pCR rate was 53 % in BluePrint HER2 patients. This is significantly superior (p = 0.047) to the pCR rate in IHC/FISH HER2+ patients (38 %). The pCR rate of 36 of 75 IHC/FISH HER2+/HR+ patients reclassified as BPLuminal is 3 %. NCT pCR for BluePrint Basal patients was 49 of 140 (35 %), comparable to the 34 of 92 pCR rate (37 %) in IHC/FISH TN patients. Conclusions: BluePrint molecular subtyping reclassifies 22 % (94/426) of tumors, reassigning more responsive patients to the HER2 and Basal categories while reassigning less responsive patients to the Luminal category. These findings suggest that compared with IHC/FISH, BluePrint more accurately identifies patients likely to respond (or not respond) to NCT. © 2014, The Author(s).

Mina L.A.,Indiana University | Yu M.,Indiana University | Johnson C.,Indiana University | Burkhardt C.,Hoosier Oncology Group | And 2 more authors.
Investigational New Drugs | Year: 2013

Purpose: Angiogenesis plays an essential role in tumor development, invasion and metastasis. We evaluated the efficacy and safety of dual angiogenesis blockade with bevacizumab and sorafenib in patients with metastatic breast cancer. Patients and Methods: Patients who had received no more than 2 prior chemotherapy regimens in any setting were treated with sorafenib 200 mg as a single oral dose daily plus bevacizumab intravenously 5 mg/kg every other week. Response was assessed by Response Evaluation Criteria in Solid Tumors (RECIST). The primary endpoint was progression free survival (PFS). Results: Eighteen patients were enrolled. Median age was 56 yo, all had good performance status KPS of 0 or 1, and 17 patients had received 1 or 2 prior chemotherapy regimens. Median PFS was 2.8 months. There were no complete or partial responses; 3 patients had stable disease for >6 months. Toxicity was substantial with 9 (50 %) patients reporting Grade 3 toxicity. Seven (39 %) patients discontinued therapy due to adverse events including hypertension (N = 2), GI toxicity (N = 1), sensory neuropathy (N = 1), rash (N = 1), pain (N = 1) and wound complication (N = 1). Given the lack of clear efficacy and increased toxicity, accrual was terminated. Conclusion: The combination of sorafenib and bevacizumab has substantial toxicity and minimal efficacy in patients with previously treated metastatic breast cancer. Further study of this combination is not recommended. © 2013 The Author(s).

Hess L.M.,Indiana University | Stehman F.B.,Indiana University | Method M.W.,Northern Indiana Cancer Research Consortium | Weathers T.D.,Indiana University | And 2 more authors.
Gynecologic Oncology | Year: 2012

Objectives: There is a lack of knowledge about the health care events experienced by individual patients that lead to a definitive diagnosis of ovarian cancer (OC). The goal of this study was to describe the various pathways and to identify an optimal path to accurate diagnosis. Methods: Women who were referred to gynecologic oncology for a suspected OC were enrolled to this study. Medical records (MRs) from all health care providers were obtained from the time the patient recalled first suspecting a health issue through the time of diagnosis to build a decision tree model. A Monte Carlo simulation was conducted of 83,000 patients to identify the optimal pathway to reach diagnosis. Results: In the Monte Carlo simulation, gynecologic oncologists and gynecologists accounted for the most efficient diagnosis in over 37.9% and 29.2% of suspected OC cases, respectively, in terms of the least amount of time to reach diagnosis. Gynecologic oncologists were further associated with the fewest health care visits needed to reach diagnosis in 37% of the simulation cases; however, 23% of trials were indifferent to any specific provider. Conclusions: The decision tree provides a more comprehensive view of the complexity in reaching an accurate diagnosis of OC. This analysis was able to identify the health care utilization patterns that underlie the events that occur to reach an accurate diagnosis in the setting of a suspected OC, and was able to identify the most efficient pathways that utilize the fewest health care resources in the least amount of time. © 2012 Elsevier Inc. All rights reserved.

Champion V.L.,Indiana University | Wagner L.I.,Northwestern University | Monahan P.O.,Indiana University | Daggy J.,Indiana University | And 11 more authors.
Cancer | Year: 2014

BACKGROUND Younger survivors (YS) of breast cancer often report more survivorship symptoms such as fatigue, depression, sexual difficulty, and cognitive problems than older survivors (OS). This study sought to determine the effect of breast cancer and age at diagnosis on quality of life (QoL) by comparing 3 groups: 1) YS diagnosed at age 45 years or before, 2) OS diagnosed between 55 and 70, and 3) for the YSs, age-matched controls (AC) of women not diagnosed with breast cancer. METHODS Using a large Eastern Cooperative Oncology Group (ECOG) database, 505 YS were recruited who were aged 45 years or younger when diagnosed and 622 OS diagnosed at 55 to 70 years of age. YS, OS, and AC were compared on physical, psychological, social, spiritual, and overall QoL variables. RESULTS Compared to both AC and to OS, YS reported more depressive symptoms (P = .005) and fatigue (P < .001), poorer self-reported attention function (P < .001), and poorer sexual function (P < .001) than either comparison group. However, YS also reported a greater sense of personal growth (P < .001) and perceived less social constraint (P < .001) from their partner than AC. CONCLUSIONS YS reported worse functioning than AC relative to depression, fatigue, attention, sexual function, and spirituality. Perhaps even more important, YS fared worse than both AC and OS on body image, anxiety, sleep, marital satisfaction, and fear of recurrence, indicating that YS are at greater risk for long-term QoL problems than survivors diagnosed at a later age. © 2014 American Cancer Society.

Allegra C.J.,University of Florida | Aberle D.R.,University of California at Los Angeles | Ganschow P.,Hospital of Cook County | Ganschow P.,Rush University Medical Center | And 13 more authors.
Journal of the National Cancer Institute | Year: 2010

Objective To provide health-care providers, patients, and the general public with a responsible assessment of currently available data on the diagnosis and management of ductal carcinoma in situ (DCIS).Participants A non-Department of Health and Human Services, nonadvocate, 14-member panel representing the fields of oncology, radiology, surgery (general and reconstructive), pathology, radiation oncology, internal medicine, epidemiology, biostatistics, nursing, obstetrics and gynecology, preventative medicine and population health, and social work. In addition, 22 experts from pertinent fields presented data to the panel and conference audience. Evidence Presentations by experts and a systematic review of the literature prepared by the Minnesota Evidencebased Practice Center, through the Agency for Healthcare Research and Quality. Scientific evidence was given precedence over anecdotal experience. Conference process The panel drafted its statement based on scientific evidence presented in open forum and on published scientific literature. The draft statement was presented on the final day of the conference and circulated to the audience for comment. The panel released a revised statement later that day at This statement is an independent report of the panel and is not a policy statement of the National Institutes of Health or the Federal Government. Conclusions Clearly, the diagnosis and management of DCIS is highly complex with many unanswered questions, including the fundamental natural history of untreated disease. Because of the noninvasive nature of DCIS, coupled with its favorable prognosis, strong consideration should be given to elimination of the use of the anxiety-producing term "carcinoma" from the description of DCIS. The outcomes in women treated with available therapies are excellent. Thus, the primary question for future research must focus on the accurate identification of patient subsets diagnosed with DCIS, including those persons who may be managed with less therapeutic intervention without sacrificing the excellent outcomes presently achieved. Essential in this quest will be the development and validation of accurate risk stratification methods based on a comprehensive understanding of the clinical, pathological, and biological factors associated with DCIS.

Jalal S.,Indiana University | Bedano P.,Clarian Hematology Oncology | Einhorn L.,Indiana University | Bhatia S.,Community Regional Cancer Center | And 7 more authors.
Journal of Thoracic Oncology | Year: 2010

Bevacizumab when combined with carboplatin and paclitaxel improves response rates (RRs) and overall survival in patients with advanced non-small cell lung cancer. Paclitaxel has single-agent activity in relapsed small cell lung cancer (SCLC). Angiogenesis seems to play an important role in the pathogenesis of SCLC. This study evaluated the safety and efficacy of paclitaxel plus bevacizumab in patients with chemosensitive relapsed SCLC. Methods: Patients with relapsed chemosensitive SCLC with an Eastern Cooperative Oncology Group performance status of 0 to 1 were eligible. They received paclitaxel 90 mg/m2 intravenously on days 1, 8, and 15. Bevacizumab was administered at 10 mg/kg intravenously on days 1 and 15. Cycles were every 28 days. The primary endpoint was progression-free survival (PFS). Secondary endpoints included RRs, toxicity, and overall survival. Correlative studies evaluated vascular endothelial growth factor polymorphisms. Results: Thirty-four patients were enrolled in the study. Median age was 66.5 (range, 38-88) years, male:female: 61.8%:38.2%, Eastern Cooperative Oncology Group performance status 0:1 47.1%:52.9%. Median progression-free survival was 14.7 weeks (equivalent to historical controls). Median survival time was 30 weeks. The overall RR was 18.1%. Stable disease rate was 39.3%, and 45.4% of patients had progressive disease. No unexpected toxicities were noted, and grade 3/4 toxicities were limited to neutropenia, fatigue, and dyspnea. None of the vascular endothelial growth factor polymorphisms evaluated were significantly associated with response. Conclusions: The addition of bevacizumab to paclitaxel does not improve outcomes in relapsed chemosensitive SCLC. Copyright © 2010 by the International Association for the Study of Lung Cancer.

Edelman M.J.,University of Maryland, Baltimore | Belani C.P.,Penn State Hershey Cancer Institute | Socinski M.A.,University of North Carolina at Chapel Hill | Ansari R.H.,Northern Indiana Cancer Research Consortium | And 4 more authors.
Journal of Thoracic Oncology | Year: 2010

BACKGROUND: Brain metastases (BMs) are a common complication of non-small cell lung cancer (NSCLC). Because of historical data indicating a poor prognosis for patients with BM, few randomized phase III studies of advanced NSCLC have included patients with BM at presentation. Because the potential benefits of systemic therapy in patients with BM are uncertain, we analyzed data from a recent phase III study. METHODS: One thousand one hundred thirty-five chemonaïve patients with stage IIIB/IV NSCLC were randomized to receive gemcitabine/carboplatin, gemcitabine/paclitaxel, or paclitaxel/carboplatin. Stratification was based on presence or absence of BM, stage, and baseline weight loss. Patients with BM were required to be clinically stable after treatment with radiotherapy or surgery before entry. Results were retrospectively analyzed by presence or absence of BM at study entry. RESULTS: Rate of BM was 17.1% overall. The response rate was 28.9% for patients with BM (n = 194) versus 29.1% without BM (n = 941). Time to progression was 4.3 months with BM and 4.6 months without BM (p = 0.03). Median survival was 7.7 months (95% confidence interval: 6.7-9.3) among patients with BM (n = 194) and 8.6 months (95% confidence interval: 7.9-9.5) for patients without BM (n = 941), p = 0.09. Rates of hematologic adverse events were not different among patients with and without BM. CONCLUSIONS: There were no significant differences in response, survival, or hematologic toxicity for patients with or without BM; however, patients with BM had a small but significantly shorter time to progression. Nonprogressing patients with treated BM are appropriate candidates for systemic therapy and entry into clinical trials. Copyright © 2009 by the International Association for the Study of Lung Cancer.

Ansari R.H.,Northern Indiana Cancer Research Consortium | Socinski M.A.,University of North Carolina at Chapel Hill | Edelman M.J.,University of Maryland, Baltimore | Belani C.P.,Penn State Cancer Institute | And 8 more authors.
Critical Reviews in Oncology/Hematology | Year: 2011

Purpose: Sufficient data are currently unavailable to assist in defining suitable regimens for patients ≥70 years with advanced non-small cell lung cancer (NSCLC). Methods: Chemonaïve patients with a performance status (PS) of 0 or 1 and stage IIIB or IV NSCLC were randomized to gemcitabine 1000mg/m2 on days 1 and 8 plus carboplatin area under the curve (AUC) 5.5 on day 1; the same schedule of gemcitabine plus paclitaxel 200mg/m2 on day 1; or paclitaxel 225mg/m2 on day 1 plus carboplatin AUC 6.0 on day 1. Cycles were every 21 days up to 6. Efficacy and toxicity results were compared by age groups. Results: Overall survival (OS) between patients <70 years (8.6 months, 95% CI: 7.9, 9.5) and ≥70 years (7.9 months, 95% CI: 7.1, 9.5) was similar. OS was 8.8 months (95% CI: 7.5, 10.3) among patients 70-74 years, 6.5 months (95% CI: 5.6, 9.3) among patients 75-79 years, and 7.9 months (95% CI: 6.3, 10.3) among patients ≥80 years. OS was lower among patients 75-79 years compared with patients 70-74 years (P=0.04). Compared with patients <70 years, patients ≥70 years experienced similar rates of myelosuppresion, but younger patients experienced more vomiting and nausea. There was no clear pattern with respect to differences in efficacy by treatments across age groups. Conclusions: Based on the similarity of patient outcomes across age groups, doublet chemotherapy is feasible among carefully selected elderly patients with good PS. © 2010 Elsevier Ireland Ltd.

PubMed | Northern Indiana Cancer Research Consortium
Type: Journal Article | Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology | Year: 2016

5094 Background: This Phase I trial will evaluate liposomal doxorubicin (Doxil) in a sequential-doublet in Primary Ovarian CA.Patients with EOC or PPC, Stage IIB - IV following initial surgery were eligible.PEG-A at dosing from 35-45mg/m2 with Carboplatin AUC 6.0-5.0 for 4 cycles every 28 days followed by Paxlitaxel at 175mg/m2/3hr with Carboplatin AUC 6.0-5.0 for 4 cycles every 21 days. Complete WHO toxicities were recorded with toxicity parameters for PPE, thrombocytopenia, and SAEs.Enrolled: 11 ovarian and 2 peritoneal CA. 12/13 were stage III or IV with all optimally cytoreduced. 12/13 completed treatment as planned. 6 received Carboplatin AUC 6.0, 4 @ 35mg/m2 and 2 @40mg/m2 of PEG-A followed by Paclitaxel 175mg/m2 and Carboplatin AUC 6.0. 3/6 had grade 2-3 platelet toxicities at cycle 7 and/or 8 with delay. Carboplatin was reduced to AUC 5.0 x 8 cycles for the next 7; 4 @ 40mg/m2 and 3 @ 45mg/m2 PEG-A x 4 followed by paclitaxel combination. 2 @ 45mg/m2 had Grade I PPE and 1 @ 45mg/m2 had grade 3 PPE after the 4Optimal dosing of this sequential doublet: PEG-A @ 40mg/m2 + Carboplatin AUC 5.0 x 4 every 28 days followed by Paclitaxel @ 175mg/m2/3hr + Carboplatin AUC 5.0 x 4 every 21 days. Minimal non-hematolgic toxicity and no alopecia during the initial 4 cycles of treatment; hematologic toxicity was manageable without factor. 25% more anthracycline was possible compared to the triplet approach with minimal neurotoxicity. Efficacy appears favorable. [Table: see text].

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