573P - Phase II study of 1st-line combined chemotherapy bevacizumab with modified RPMI regimen for elderly or frail patients with unresectable or metastati...

Date 01 October 2012
Event ESMO Congress 2012
Session Poster presentation III
Topics Anti-Cancer Agents & Biologic Therapy
Geriatric Oncology
Colon Cancer
Rectal Cancer
Presenter Motoki Yoshida
Authors M. Yoshida1, T. Kato2, S. Iwamoto3, Y. Miyake2, M. Nakamura4, T. Sato5, D. Sakai6, M. Matsuoka7, T. Otsuji7, H. Furukawa8
  • 1Cancer Chemotherapy Center, Osaka Medical College, 569-8686 - Takatsuki/JP
  • 2Department Of Surgery, Minoh City Hospital, 562-0014 - Osaka/JP
  • 3Surgery, Kansai Medical University School Hirakata Hospital, Osaka/JP
  • 4Aizawa Comprehensive Cancer Center, Aizawa Hospital, 390-8510 - Matsumoto/JP
  • 5Kinki University Hospital, Faculty Of Medicine, Medical Oncology, Osaka/JP
  • 6Osaka Medical Center For Cancer And Cardiovascular Disease, Medical Oncology, Osaka/JP
  • 7Gastroenterology, Dongo Hospital, Nara/JP
  • 8Surgery, Kinki University School of Medicine, Osaka/JP

Abstract

Background/ Objectives

The first-line combined chemotherapy RPMI regimen with bevacizumab (Bmab) in AVF2192g trial for elderly or frail patients (Pts) could be active to progression free survival (PFS), the secondary endpoint, although it may not prolong overall survival (OS), the primary endpoint. According to the results of efficacy and safety studies, a fluoropyrimidine (FU) + Bmab regimen is regarded as an option for 1st-line chemotherapy. We planned a phase II study of modified RPMI regimen with Bmab for elderly or frail Pts.

Methods

Pts with confirmed unresectable/metastatic colorectal cancer without previous chemotherapy, and fulfilling at least one of the following characteristics were enrolled: Age ≧65 years, ECOG performance status 1 or 2, serum albumin ≦ 3.5g/dl, incompatible with receiving oxaliplatin or irinotecan, or prior abdominal/pelvic radiotherapy. Pts received modified RPMI regimen (5-FU 600 mg/m2 and l-leucovorin 200 mg/m2 bolus day 1, 8, 15) and Bmab 5 mg/kg day 1, 15, q4w) until disease progression or study withdrawal. The primary endpoint was overall response rate (ORR), and the secondary endpoints were PFS, OS, safety and treatment completion rate of treatment.

Results

41 Pts (mean age 76 years [range 56–90]; 55% male) were enrolled to this trial from 13 institutions. 28 Pts (68%) had objective progression and a patient (2.4%) died without progression. The ORR, the primary endpoint, the rate of best response, the disease control rate (CR + PR + SD) were 36.6%, 56.1%, 85.4%, respectively. The median PFS was 9.0 months (95%CI, 7.5–19.6) by independent central review. Median OS was 30.2 months (95%CI, 23.8–Not achieved). Mean 5-FU and Bmab dose intensity were 86.9% and 83.6%, respectively. The incidences of all grade/grade 3-4 adverse events: leukopenia (66/7), neutropenia (58/24), thrombocytopenia (39/2), nausea (29/0), diarrhoea (34/5), anorexia (32/10), fatigue (49/5), stomatitis (29/7) and hypertension (24/5). Grade 3 febrile neutropenia and grade 4 pulmonary embolism was observed in one patient.

Conclusions

The modified RPMI regimen with Bmab showed activity, and was well tolerated by elderly or frail Pts. ORR and the median PFS of this regimen were similar to historical data with FU + Bmab. This regimen may be a good option not requiring percutaneous port placement for elderly or frail Pts. .

Disclosure

M. Yoshida: The author received few payments for lectures from Chugai Pharmaceutical Co., Ltd. Grants for research were also provided to the Chemotherapy Center of Osaka Medical College by this pharmaceutical companies.

All other authors have declared no conflicts of interest.