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Naeim A.,University of California at Los Angeles | Ward P.R.,University of California at Los Angeles | Wang H.-J.,University of California at Los Angeles | Dichmann R.,Translational Oncology Research International TORI | And 7 more authors.
Journal of Geriatric Oncology | Year: 2013

Objectives: This study aims to determine the efficacy and tolerability of capecitabine (CAP) plus bevacizumab (BEV) as treatment for frontline metastatic colorectal cancer (mCRC) in frail and/or elderly patients. Materials and Methods: This was an open label, multi-site, single arm, phase II study in frontline mCRC. In this study, patients (pts) who were frail (ECOG 2) or older patients with ECOG 1 performance status (PS) received CAP (1000mg/m2 bid, 14days of every 21days) plus BEV (7.5mg/kg iv once every 21days). The primary objective was progression free survival (PFS). Secondary objectives were overall response rate (ORR) and toxicity. Results: In terms of patients: 50 were enrolled; 5 withdrew consent prior to treatment; 45 were treated, and 41 were evaluable. The mean age was 75.9 (range 54-93) and 62% had an ECOG 2 PS. The median PFS was 6.87. months (95% CI, 5.1-11.5. months) and median overall survival was 12.7. months (95% CI, 6.9-12.7. months). The most common grades 3-4 toxicities were: diarrhea (17.8%), fatigue (13.3%), hand-foot syndrome (13.3%), dehydration (8.9%), hypertension (6.7%) and vomiting (6.7%). Conclusions: The results of this trial support the use of CAP plus BEV as first-line treatment for frail/elderly patients with metastatic CRC. The ORR (40%) is comparable to pooled data in elderly on fluorouracil (5-FU). +. BEV. The median PFS (7.2. months) in this study is slightly lower than that seen with 5-FU. +. BEV but this study had a high percentage of ECOG PS 2 patients. Side effects were manageable with no new safety signals. © 2013 Elsevier Inc.

Ward P.,University of California at Los Angeles | Hecht J.R.,University of California at Los Angeles | Wang H.-J.,University of California at Los Angeles | Dichmann R.,Translational Oncology Research International TORI | And 7 more authors.
Journal of Geriatric Oncology | Year: 2014

Objectives: Optimal treatment strategies in frail and/or elderly patients with metastatic colorectal cancer have not been well defined. Using data from a prospective, phase II study of elderly patients with metastatic colorectal cancer treated with bevacizumab and capecitabine, we explored the differences in functional measure and quality of life (QoL) between patients with ECOG performance status (PS) 1 and 2. Materials and Methods: Geriatric functional measures included patient reported limitations in ADLs and IADLs, ECOG PS, 3-item recall, hearing acuity, and the "Get up and Go" test. QoL was assessed by means of the FACT-C questionnaire and the EQ-5D questionnaire. The prognostic impact of baseline characteristics on survival was studied using univariate Cox regression analysis. Results: The majority (62%) of the 45 patients had an ECOG PS of 2. The ECOG PS 2 group had more limitations in IADLs, lower baseline QoL, and a lower patient-rated health score. For all participants, QoL significantly improved from baseline to the start of cycle 2 (FACT-C: 99.9 vs. 105.4, p= 0.01) and did not deteriorate when baseline scores were compared to when participants went off study (FACT-C: 99.9 vs. 98.6, p= 0.59). In the Cox-regression analysis, a positive "Get up and Go" test was prognostic for improved survival (HR = 0.31, p= 0.01). Conclusion: There is significant heterogeneity in functional measures and quality of life among elderly patients with metastatic colorectal cancer with ECOG PS 1 and 2. The "Get up and Go" test may be a useful prognostic indicator for survival in this population. © 2014 Elsevier Inc.

Wainberg Z.A.,University of California at Los Angeles | Lin L.-S.,Translational Oncology Research International TORI | Dicarlo B.,Translational Oncology Research International TORI | Dao K.M.,Translational Oncology Research International TORI | And 6 more authors.
British Journal of Cancer | Year: 2011

Background: There is increased recognition that cancers of the upper GI tract comprise distinct epidemiological and molecular entities. Erlotinib has shown activity in patients with adenocarcinoma of the oesophagus/gastro- oesophageal junction (GEJ), but not in distal gastric cancer. mFOLFOX6 is one of several active regimens used to treat adenocarcinoma of the Eso/GEJ. This study evaluates the efficacy and safety of mFOLFOX6 and erlotinib in patients with metastatic or advanced Eso/GEJ cancers. Methods: Patients with previously untreated advanced or metastatic Eso/GEJ adenocarcinoma are treated with oxaliplatin 85 mg m-2, 5-FU 400 mg m-2, LV 400 mg m-2 on day 1, 5-FU 2400 mg m-2 over 48 h and erlotinib 150 mg PO daily. Treatment was repeated every 14 days. The primary objective was response rate (RR), secondary objectives include toxicity, progression-free survival (PFS), overall survival (OS) and to correlate clinical outcome with expression patterns and molecular alterations in the epidermal growth factor receptor-dependent pathways. Results: A total of 33 patients were treated and evaluable: there were two complete responses, 15 partial responses for an objective RR of 51.5% (95% CI, 34.5-68.6%). Median PFS was 5.5 months (95% CI, 3.1-7.5 months) and median OS was 11.0 months (95% CI, 8.0-17.4 months). The most common grade 3-4 toxicities were: diarrhoea (24%), nausea/vomiting (11%), skin rash (8%) and peripheral neuropathy (8%). The frequency of alterations was KRAS mutations (8%), EGFR mutations (0%) and HER2 amplification (19%). Conclusion: In patients with Eso/GEJ adenocarcinoma, mFOLFOX6 and erlotinib is active, has an acceptable toxicity profile and FOLFOXerlotinib could be considered for further development. © 2011 Cancer Research UK All rights reserved.

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