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.

Abstract

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.

• Authors: Yun Wang, Jørn Herrstedt, Hanne Havsteen, Rene DePoint Christensen, Mansoor Raza Mirza, Bente Lund, Johanna Maenpaa, Gunnar Kristensen
• Journal: BMC cancer (BMC Cancer) Vol. 14 Pg. 937 (Dec 11 2014) ISSN: 1471-2407 [Electronic] England
• PMID: 25494701 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Taxoids
• Docetaxel
• Carboplatin

Topics

• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects)
• Carboplatin (administration & dosage, adverse effects)
• Carcinoma (drug therapy)
• Carcinoma, Ovarian Epithelial
• Chemotherapy-Induced Febrile Neutropenia (etiology)
• Disease Progression
• Disease-Free Survival
• Docetaxel
• Drug Screening Assays, Antitumor
• Fallopian Tube Neoplasms (drug therapy)
• Female
• Humans
• Middle Aged
• Neoplasm Recurrence, Local (drug therapy)
• Neoplasms, Glandular and Epithelial (drug therapy)
• Ovarian Neoplasms (drug therapy)
• Peritoneal Neoplasms (drug therapy)
• Prospective Studies
• Somatosensory Disorders (chemically induced)
• Taxoids (administration & dosage, adverse effects)
• Treatment Outcome
• Young Adult