Phase II trial of chemotherapy plus bevacizumab as second-line therapy for patients with metastatic colorectal cancer that progressed on bevacizumab with chemotherapy: the Gunma Clinical Oncology Group (GCOG) trial 001 SILK study.
OBJECTIVE
BRiTE and ARIES (observational cohort studies) provided valuable information on continued use of bevacizumab (BV) beyond progression (BBP). This trial evaluates the efficacy and safety of BBP for patients with metastatic colorectal cancer that progressed on first-line chemotherapy.


METHODS
A total of 39 patients received FOLFIRI + BV (after FOLFOX + BV) or FOLFOX + BV (after FOLFIRI + BV) as protocol treatment. The primary endpoint was the response rate. Secondary endpoints were overall survival (OS), total survival from initiation of first-line treatment (TS), progression-free survival (PFS), and safety.


RESULTS
All 39 treated patients were evaluated for toxic effects. Two patients did not meet all of the eligibility criteria and were excluded from efficacy analyses. The response rate was 16.2%. The disease control rate was 76%. The median PFS was 150 days (range 117-224). The median OS was 417 days (range 233-813). The median TS was 988 days (range 600-1,268). Grade 3/4 adverse events (% of patients) related to treatment were neutropenia (33%), fatigue (23%), and hypertension (18%).


CONCLUSIONS
This is the first report to show the effect of BBP in patients who had progressive disease on first-line treatment including BV confirmed by RECIST criteria. This analysis suggests the possibility of prolonged survival with continued use of BV.
Department of General Surgical Science, Gunma University, Graduate School of Medicine, Maebashi, Gunma, Japan. chuchumi@showa.gunma-u.ac.jp
Soichi
S
Tsutsumi
Keiichiro
K
Ishibashi
Nobuyuki
N
Uchida
Hitoshi
H
Ojima
Yasuo
Y
Hosouchi
Naokuni
N
Yashuda
Wakako
W
Kigure
Satoru
S
Yamauchi
Takayuki
T
Asao
Hideyuki
H
Ishida
Hiroyuki
H
Kuwano
D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000068258:Bevacizumab; D002166:Camptothecin / Q000031:analogs & derivatives / Q000627:therapeutic use; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D018450:Disease Progression; D005260:Female; D005472:Fluorouracil / Q000627:therapeutic use; D006801:Humans; D002955:Leucovorin / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D009944:Organoplatinum Compounds / Q000627:therapeutic use; D015996:Survival Rate; D016896:Treatment Outcome
D061067:Antibodies, Monoclonal, Humanized; D009944:Organoplatinum Compounds; D000068258:Bevacizumab; D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin