Capecitabine and bevacizumab as first-line treatment in elderly patients with metastatic colorectal cancer

e15074 Background: The aim of this prospective study was to evaluate efficacy and safety of bevacizumab in combination with capecitabine as first line treatment in elderly patients with MCC. Methods: 40 elderly patients (median age 75 years) with MCC have been treated with bevacizumab in combination with capecitabine as their first line therapy. Regimen consisted of bevacizumab 7.5 mg mg/kg on day 1 plus capecitabine 1000 mg/m2 on day 1–14 followed by 7 days rest. Results: The median follow up time at time of ASCO will be 12 months. Median number of 9 cycles was administrated, ranging from 1 to 23. 3 patients (7.5 %) had complete response, 19 patients (47.5 %) had partial response, 11 patients (27.5 %) had stable disease, 1 patient (2.5 %) progressed according to RECIST criteria and 6 patients (15%) were not evaluated yet. Until this report 15 of 40 patients progressed and 9 of 40 patients died. Median time to progression is 6.37 months. Median overall survival will be reported at ASCO 2009 meeting. The most common hematological adverse events were mild (grade I and II): anemia (27.5%) neutropenia (22.5%), and thrombocytopenia (20%). The most common non-hematological toxicity were mild as well (grade I and II): hand-foot syndrome (70%), arterial hypertension (52.5%), proteinuria (45%), hyperbilirubinemia (45%), diarrhea (25%), loss of appetite (23.5%), fever (22.5%), fatigue (17.5%), tearing (17.5%), and nail changes (12.5%). Grade 3 and 4 adverse events occurred rarely: hand-foot syndrome (12.5%), deep vein thrombosis (7.5%), fever (5%), and arterial hypertension (2.5%). Conclusions: This prospective phase II study has demonstrated that bevacizumab in combination with capecitabine as first line treatment in elderly patients with metastatic colorectal cancer is an effective and well-tolerated regimen. [Table: see text]

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Phase II trial of modified FOLIRI plus Panitumumab as first-line treatment in elderly patients with RAS wild-type metastatic colorectal cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.e15053 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. e15053-e15053

Author(s):

Athanasios Karampeazis ◽

Lampros Vamvakas ◽

Nikolaos K. Kentepozidis ◽

Athanasios Kotsakis ◽

Kostas Kalbakis ◽

...

Keyword(s):

Colorectal Cancer ◽

Elderly Patients ◽

Metastatic Colorectal Cancer ◽

Phase Ii ◽

Phase Ii Trial ◽

Line Treatment ◽

Wild Type ◽

First Line ◽

Grade 3 ◽

First Line Treatment

e15053 Background:The role of combination chemotherapy plus anti-EGFR treatment in older patients with metastatic colorectal cancer (mCRC) is unclear. We conducted an open label phase II trial in order to evaluate the safety and efficacy of modified FOLFIRI plus panitumumab as first-line treatment in elderly patients with RAS wild-type mCRC. Methods: Patients ≥70 years old with unresectable all-RAS wild-type mCRC were treated with Panitumumab 6mg/kg as 60min iv infusion followed by Irinotecan 130mg/m2 as 90min iv infusion, Leucovorin 400mg/m2 as 2h iv infusion and 5-Fluorouracil 400mg/m2 as bolus iv infusion on day 1 and 5-Fluorouracil 1.200 mg/m2 as continuous iv infusion for 46h, every 2 weeks. Sample size calculation was based on the minimax Simon two-step design: The null hypothesis was that the overall response rate (ORR) is ≤ 30% versus the alternative hypothesis of ORR ≥ 50% (α = 0.05, power 80%). Results: Forty-six patients were enrolled in the study. Two patients did not receive treatment because they were RAS mutant. Median age for the 44 treated patients was 76 years (range 70-88). Males were 32 and the PS was 0, 1 and 2 in 25%, 70.5% and 4.5% of patients, respectively. Rectal cancer accounted for 25% while 15.9% of patients had the primary tumour in situ. Twenty-one partial responses were observed for an ORR of 47.7% (95%CI: 32.9%-62.5%) while seven patients (15.9%) had stable disease. After a median follow-up of 36.0 months, the median progression-free survival was 6.1 months (95%CI: 3.6-8.7) and the median overall survival was 20.9 months (95%CI: 11.7-30.1). Grade 3-4 neutropenia was recorded in 4 (9%) and grade 3-4 diarrhea in 9 (20.4%) patients while one patient had a grade 4 bowel perforation. One patient experienced grade 3 mucositis, two patients grade 3 skin toxicity and two patients grade 3 fatigue. There were no toxic deaths while one patient died due to bowel obstruction and one due to postoperative complications after removal of the primary tumor. Conclusions: The modified FOLFIRI plus panitumumab combination presented significant efficacy with manageable toxicity in elderly patients with mCRC.

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First-line biological agents plus chemotherapy in elderly patients with metastatic colorectal cancer: A retrospective pooled analysis.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.4017 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. 4017-4017

Author(s):

Pilar Garcia-Alfonso ◽

Eduardo Diaz-Rubio ◽

Albert Abad ◽

Alfredo Carrato ◽

Bartomeu Massuti ◽

...

Keyword(s):

Colorectal Cancer ◽

Elderly Patients ◽

Metastatic Colorectal Cancer ◽

Biological Agents ◽

Comparable Efficacy ◽

Line Treatment ◽

First Line ◽

Younger Patients ◽

Significant Difference ◽

First Line Treatment

4017 Background: Biological agents, in combination with chemotherapy, are recommended as first-line treatment of metastatic colorectal cancer (mCRC); however, evidence guiding appropriate management of elderly patients with mCRC is lacking. This study compared the efficacy and safety outcomes in older versus younger patients with mCRC who received first-line biological therapy. Methods: This retrospective analysis used pooled data from five Spanish TTD collaborative group studies of adults with advanced CRC who received first-line treatment with bevacizumab, cetuximab or panitumumab, stratified by age (≥65 vs < 65 years). Endpoints included progression-free survival (PFS), overall survival (OS), overall response rate (ORR) and safety. Results: In total, 999 patients from five studies were included in the analysis; 480 (48%) were aged ≥65 years and 519 (52%) were aged < 65 years; 733 (73.37%) were treated with bevacizumab, 189 (18.92%) received cetuximab and 77 (7.71%) received panitumumab. Median PFS did not significantly differ between patients aged ≥65 versus < 65 years (9.9 vs 9.4 months; hazard ratio [HR] 1.01; 95% confidence interval [CI] 0.88–1.17). Median OS was significantly shorter in older versus younger patients (21.3 vs 25.0 months; HR 1.21; 95% CI 1.04–1.41; P = 0.0132). There was no significant difference between older versus younger patients in ORR (59% vs 62%). Older patients experienced more treatment-related grade ≥3 adverse events. Conclusions: Biological agents are an effective first-line treatment option for elderly patients with mCRC, with comparable efficacy in PFS and ORR to that observed in younger patients and a manageable safety profile.

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