A single-arm study evaluating bevacizumab, cisplatin, and paclitaxel followed by single-agent bevacizumab in Japanese patients with advanced cervical cancer.
BACKGROUND
Adding bevacizumab to chemotherapy for recurrent, persistent or metastatic cervical cancer significantly improved overall survival (primary endpoint), progression-free survival and overall response rate in the randomized Phase III GOG-0240 trial. However, data for bevacizumab-containing therapy are scarce in Japanese patients with advanced cervical cancer.


METHODS
The primary objective of the single-arm multicenter Phase II JO29569 study was to evaluate the tolerability of paclitaxel (135 mg/m2over 24 h or 175 mg/m2over 3 h), cisplatin (50 mg/m2) and bevacizumab (15 mg/kg), administered every 3 weeks until disease progression or unacceptable toxicity in Japanese patients with stage IVB, persistent or recurrent cervical cancer.


RESULTS
The seven treated patients received a median of nine (range 7-12) bevacizumab cycles and six (range 4-12) chemotherapy cycles. None of the predefined adverse events occurred during the tolerability evaluation period. The most common all-grade adverse events were alopecia, hypertension, decreased appetite, nausea and peripheral sensory neuropathy. There were no cases of fistula. The most common grade ≥3 adverse events were hypertension, neutrophil count decreased and neutropenia. Only one patient experienced febrile neutropenia. The overall response rate was 86% (95% confidence interval, 42-100%), including a complete response in one patient. At data cutoff, disease had progressed in one patient; bevacizumab therapy was ongoing in the remaining six.


CONCLUSIONS
According to the specified primary objective, a regimen of cisplatin, paclitaxel and bevacizumab was tolerable in Japanese patients and demonstrated encouraging activity in this small single-arm study. Further study is warranted to confirm the safety and effectiveness of bevacizumab in Japanese patients with cervical cancer.
Iwate Medical University School of Medicine, Morioka sugiyama@iwate-med.ac.jp.
Toru
T
Sugiyama
Aichi Cancer Center, Nagoya.
Mika
M
Mizuno
University of the Ryukyus, Nishihara.
Yoichi
Y
Aoki
University of Tsukuba, Tsukuba.
Manabu
M
Sakurai
National Cancer Center Hospital, Tokyo.
Tadaaki
T
Nishikawa
Chugai Pharmaceutical Co., Ltd, Tokyo.
Eisuke
E
Ueda
Chugai Pharmaceutical Co., Ltd, Tokyo.
Kosei
K
Tajima
Cancer Institute Hospital of JFCR, Tokyo, Japan.
Nobuhiro
N
Takeshima
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D044466:Asian People; D000068258:Bevacizumab / Q000008:administration & dosage*; D002945:Cisplatin / Q000008:administration & dosage*; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007564:Japan; D008875:Middle Aged; D009325:Nausea / Q000209:etiology; D009364:Neoplasm Recurrence, Local; D009503:Neutropenia / Q000209:etiology; D017239:Paclitaxel / Q000008:administration & dosage*; D016896:Treatment Outcome; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy*
D000068258:Bevacizumab; D017239:Paclitaxel; D002945:Cisplatin
Japanese; anti-angiogenic; bevacizumab; cervical cancer