Bevacizumab combined with platinum-taxane chemotherapy as first-line treatment for advanced ovarian cancer: a prospective observational study of safety and efficacy in Japanese patients (JGOG3022 trial).

Abstract

BACKGROUND:

This was the first large-scale prospective observational Japanese study evaluating the safety and efficacy of bevacizumab combined with paclitaxel and carboplatin for newly diagnosed advanced ovarian cancer.

METHODS:

Patients were prospectively enrolled in the primary analysis cohort if they had Stage III or IV epithelial ovarian/fallopian tube/primary peritoneal cancer and were scheduled to receive paclitaxel plus carboplatin every 3 weeks in Cycles 1-6 and bevacizumab every 3 weeks in Cycles 2-22. Primary endpoints were bevacizumab-specific adverse events and adverse events ≥ Grade 3. Secondary endpoints were progression-free survival (PFS) and the response rate.

RESULTS:

Among 346 patients enrolled, 293 patients formed the primary analysis cohort. Regarding bevacizumab-specific adverse events ≥ grade 3, incidence rates of thromboembolic events (1.4%), gastrointestinal perforation (0.3%), fistula (0.7%), wound dehiscence (0%), and bleeding (0%) were very low. While incidence rates of hypertension (23.2%) and proteinuria (12.6%) were high, all such events were tolerable. No patient with prior bowel resection developed perforation or fistula. Median PFS was 16.3 months (95% CI 14.5-18.9). The response rate was 77.5% (95% CI 67.4-85.7). The response rate was 63.6% in patients with clear cell carcinoma, which tended to be better than previously reported. The median platinum-free interval was 11.5 months, and the platinum-resistant recurrence rate was 24.5%.

CONCLUSIONS:

Combining bevacizumab with chemotherapy was tolerable and efficacy was acceptable in Japanese patients with advanced epithelial ovarian cancer. Bevacizumab seems to reduce platinum-resistant recurrence and is promising for clear cell carcinoma.

• Authors: Shinichi Komiyama, Kazuyoshi Kato, Yuki Inokuchi, Hirokuni Takano, Takashi Matsumoto, Atsushi Hongo, Mikiko Asai-Sato, Atsushi Arakawa, Shoji Kamiura, Tsutomu Tabata, Nobuhiro Takeshima, Toru Sugiyama
• Journal: International journal of clinical oncology (Int J Clin Oncol) Vol. 24 Issue 1 Pg. 103-114 (Jan 2019) ISSN: 1437-7772 [Electronic] Japan
• PMID: 30030657 (Publication Type: Journal Article, Observational Study)

Chemical References

• Docetaxel
• Bevacizumab
• Carboplatin
• Paclitaxel

Topics

• Adenocarcinoma, Clear Cell (drug therapy, pathology)
• Adenocarcinoma, Mucinous (drug therapy, pathology)
• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Bevacizumab (administration & dosage)
• Carboplatin (administration & dosage)
• Cystadenocarcinoma, Serous (drug therapy, pathology)
• Docetaxel (administration & dosage)
• Endometrial Neoplasms (drug therapy, pathology)
• Female
• Humans
• Japan
• Middle Aged
• Neoplasm Recurrence, Local (drug therapy, pathology)
• Ovarian Neoplasms (drug therapy, pathology)
• Paclitaxel (administration & dosage)
• Prognosis
• Prospective Studies
• Safety
• Survival Rate
• Young Adult