Camden, NJ, United States
Camden, NJ, United States

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Stevenson J.P.,University of Pennsylvania | Langer C.J.,University of Pennsylvania | Somer R.A.,Cooper Cancer Institute | Evans T.L.,University of Pennsylvania | And 9 more authors.
Cancer | Year: 2012

Background: The authors performed a phase 2 study of bevacizumab plus pemetrexed and carboplatin followed by maintenance bevacizumab in patients with advanced, nonsquamous nonsmall cell lung cancer. Methods: Previously untreated patients with advanced, nonsquamous nonsmall cell lung cancer and an Eastern Cooperative Oncology Group performance status of 0 or 1 received bevacizumab 15 mg/kg, pemetrexed 500 mg/m2 and carboplatin at an area under the concentration-time curve of 6 intravenously on day 1 every 21 days. Responding or stable patients who completed 6 cycles then received bevacizumab maintenance every 21 days until disease progression. Results: In total, 43 patients (40 who were evaluable for response) were entered on the study. Treatment-related grade 3/4 toxicities were low and included febrile neutropenia (2%), neutropenia (28%), anemia (18%), thrombocytopenia (11%), hypertension (7%), epistaxis (5%), venous thrombosis (8%), dyspnea (7%), rectovaginal fistula (2.3%), infusion reaction (2%), and cerebrovascular event (2%). One patient died from complications of venous thromboembolism and cerebrovascular accident after Cycle 2. Minimal clinically significant toxicity occurred during maintenance bevacizumab. Two complete responses (5%) were observed, and 17 patients (42%) had a partial response. Fifteen patients (38%) displayed disease stability. The overall disease control rate was 85%. At a median follow-up of 15.8 months, the median progression-free survival was 7.1 months (95% confidence interval, 5.9-8.3 months), and the median overall survival was 17.1 months (95% confidence interval, 8.8-25.5 months). Conclusions: Combined bevacizumab, pemetrexed, and carboplatin followed by maintenance bevacizumab was well tolerated and displayed remarkable activity in patients with previously untreated, advanced, nonsquamous nonsmall cell lung cancer. © 2012 American Cancer Society.

Esteva F.J.,University of Houston | Franco S.X.,Memorial Cancer Institute | Hagan M.K.,Virginia Cancer Institute | Brewster A.M.,University of Houston | And 6 more authors.
Oncologist | Year: 2013

Background. Recent data support the hypothesis that combining lapatinib and trastuzumab with taxane chemotherapy may offer added clinical benefit to patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC). This study examined the safety of the triplet combination in first-line HER2-positive MBC. Patients and Methods. Patients were enrolled into three sequential cohorts; the last two cohorts were added by protocol amendmentfollowing review of safety data from cohort 1. Patients in cohort 1 received lapatinib (1000 mg/day) plus paclitaxel (80 mg/m2 per week, 3 of every 4 weeks); cohort 2 received lapatinib (1000 mg/day) plus paclitaxel (70 mg/m2 per week, 3 of every 4 weeks); and cohort 3 received lapatinib (750 mg/day) plus paclitaxel (80mg/m2 per week, 3 of every 4 weeks). All received standard trastuzumab dosing. The primary objective was assessment of dose-limiting toxicities, safety, and tolerability of this combination. Results. The most frequent adverse events (AEs) for all cohorts were diarrhea (89%), rash (79%), fatigue (73%), alopecia (63%), nausea (63%), and vomiting (40%). In cohorts 1 and 2, the incidence of grade 3 diarrhea was 62% and 50%, respectively; in cohort 3, the incidence was 25% (with prophylactic loperamide). Dehydration was the most frequent serious AE (10%). Across cohorts, overall response rate was 75%. Conclusions. The dose-limiting toxicity of paclitaxel, trastuzumab, and lapatinib in first-line HER2-positiveMBCwas diarrhea. Of the triplet combinations tested, the cohort receiving 750 mg/day dose of lapatinib had the lowest incidence of diarrhea; therefore, this dose should be used in further studies on the treatment of MBC. © AlphaMed Press 2013.

PubMed | Cooper Cancer Institute
Type: Journal Article | Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology | Year: 2016

11529 Background: Neoadjuvant treatment for operable breast cancer is increasing based on clinical guidelines that are typically derived from randomized phase 3 cooperative group trials whose results establish a standard of care. However, the majority of cancer therapy is given in the community. There is controversy about the applicability of these studies to community practice. The National Surgical Adjuvant Breast and Bowel Project (NSABP) B-27 (JCO (24)2019-27, 2006) found the preoperative addition of four cycles of docetaxel to four cycles of AC significantly improved response rates in women with operable breast cancer. We studied whether community practice can achieve similar results in women with operable breast cancer treated in a neoadjuvant approach.Retrospective analysis of a cancer registry database from a community center consisting of 36 women with operable breast cancer who were treated preoperatively with four cycles of doxorubicin and cyclophosphamide followed by docetaxel was performed. Clinical and pathologic response to therapy was evaluated and compared to the peer-reviewed, published standard.Of 36 patients reviewed, a total of 21 patients were identified for analysis. The average age of the patient was 54. The average tumor size was 6.4 cm, with 48% having estrogen receptor (ER) positive disease. The complete clinical response (CCR) was found to be 42.9% v 63.6%, p = 0.066; the partial clinical response (PCR) 38.1% v 27.1%, p = 0.320; the overall clinical response (CCR + PCR) 81.0 v 90.7; and the complete pathologic response (CPR) 23.8% v 26.1%, p = 1.00, compared to results published in NSABP B27, respectively. The data was tested against the standard as established by the NSABP B-27 by using the Fisher exact test. There were no significant differences between the two groups in regards to response rates. Sample size was too small to compare disease-free and overall survival.Although our sample contained a large proportion of ER positive tumors, women with operable breast cancer treated with four cycles of doxorubicin and cyclophosphamide followed by four cycles of docetaxel in the community setting achieve similar outcomes compared to national standards. Current breast cancer trials reflect community practice. No significant financial relationships to disclose.

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