A multicenter, non-randomized, phase II study of docetaxel and carboplatin administered every 3 weeks as second line chemotherapy in patients with first relapse of platinum sensitive epithelial ovarian, peritoneal or fallopian tube cancer

BMC Cancer

Yun Wang⁴  Jørn Herrstedt¹  Hanne Havsteen¹  Rene DePoint Christensen²  Mansoor Raza Mirza⁶  Bente Lund⁵  Johanna Maenpaa³  Gunnar Kristensen⁷ 

[1] Department of Oncology, Herlev University Hospital, Herlev, Denmark

[2] Research Unit of General Practice, Institute of Public Health, University of Southern Denmark, Odense, Denmark

[3] Department of Obstetrics and Gynecology, School of Medicine, University and University Hospital of Tampere, Tampere, Finland

[4] Department of Gynecologic Oncology, Norwegian Radium Hospital, Oslo University Hospital, PB 4953 Nydalen 0424, Oslo, Norway

[5] Department of Oncology, Ålborg University Hospital, Ålborg, Denmark

[6] Department of Oncology, Odense University Hospital, Odense, Denmark

[7] Department of Gynecologic Oncology and Institute for Medical Informatics, Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway

关键词: Toxicity;    Carboplatin;    Docetaxel;    Recurrent platinum-sensitive ovarian cancer;    Phase II study;   

Others  :  1117906
DOI  :  10.1186/1471-2407-14-937

 received in 2014-05-13, accepted in 2014-11-20,  发布年份 2014

【 摘 要 】

Background

In patients with ovarian cancer relapsing at least 6 months after end of primary treatment, the addition of paclitaxel to platinum treatment has been shown to improve survival but at the cost of significant neuropathy. In the first line setting, the carboplatin-docetaxel combination was as effective as the combination of carboplatin and paclitaxel but with less neurotoxicity. This study was initiated to evaluate the feasibility of carboplatin with docetaxel as second line treatment in patients with ovarian, peritoneal or fallopian tube cancer.

Methods

Patients with stage IC-IV epithelial ovarian, peritoneal or fallopian tube cancer were enrolled at the first relapse after at least 6 months since completion of the first line treatment. Docetaxel 75 mg/m² was given as an one hour IV infusion followed immediately by carboplatin (AUC = 5) given as a 30–60 min. IV infusion on day 1 and repeated every 3 weeks for 6–9 courses. Primary endpoint was toxicity; secondary endpoints were response rate and the time to progression.

Results

A total of 74 patients were included. Of these, 50 patients received 6 or more cycles, 13 received 3–5 courses and 11 received less than 3 courses. A total of 398 cycles were given. Grade 3/4 neutropenia was seen in 80% (59 of 74) patients with an incidence of febrile neutropenia of 16%. Grade 2/3 sensory peripheral neuropathy occurred in 7% of patients, but no grade 4 sensory peripheral neuropathy was observed. Sixty patients were evaluable for response. The overall response rate was 70% with 28% complete responses in the response evaluable patient population. Median progression-free survival was 12.4 months (95% CI 10.4-14.4).

Conclusions

The three-weekly regimen of docetaxel in combination with carboplatin was feasible and active as second-line treatment of platinum-sensitive ovarian, peritoneal and Fallopian tube cancer. The major toxicity was neutropenia, while the frequency of peripheral neuropathy was low.

【 授权许可】

   
2014 Wang et al.; licensee BioMed Central.

【 图 表 】

Figure 1.

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