The phase II study of efficacy and safety of oxaliplatin with doxorubicin in recurrent ovarian cancer (OC).

Authors

Ilya Pokataev

I. Pokataev

N. N. Blokhin Cancer Research Center, Russian Academy of Medical Sciences, Moscow, Russia

I. Pokataev , G. M. Manikhas , V. Borisov , M. Stenina , A. Tjulandina , S. Tjulandin

Organizations

N. N. Blokhin Cancer Research Center, Russian Academy of Medical Sciences, Moscow, Russia, City Clinical Oncology Center, St. Petesburg, Russia, 1st Moscow Cancer Hospital, Moscow, Russia

Research Funding

Pharmaceutical/Biotech Company

Background: There is no current standard of salvage chemotherapy in recurrent OC. Oxaliplatin is an effective third generation platinum compound which has no complete cross-resistance with carboplatin or cisplatin in OC. The purpose of our study was to assess efficacy and tolerability of combination of oxaliplatin and doxorubicin in second-line chemotherapy of OC. Methods: In case of disease progression following first-line chemotherapy pts received second-line chemotherapy with oxaliplatin 130 mg/m2 and doxorubicin 50 mg/m2 q3w. Time to progression (TTP) was chosen as the primary end-point. Three investigator centers participated in the study. Results: Totally 29 pts were included in this study. Tumors were platinum-sensitive (PFI>12 m) in 5 (17.2%), partially platinum-sensitive (PFI>6 m) in 12 (41.4%), platinum-resistant (PFI<6 m) in 11 (38.0%) cases, in 1 (3.4%) case sensitivity of tumor to platinum was not known. Objective response rate was 55.1% (24.1% complete remissions and 31.0% partial remissions). The median TTP was 10.7 m. With the median f.-up of 14.8 m the median overall survival was not reached. 1-year overall survival was 89%. There were no statistically significant differences in response rate and TTP between platinum-sensitive and platinum-resistant cancers (p>0.05). The median number of cycles was 5 (range 2-6). Toxicity grade 3-4 per cycle included neutropenia 14.6%, febrile neutropenia 0.7%, thrombocytopenia 5.1%. Sensory neuropathy grade 1-2 and 3 was observed in 8 (27.6%) and 2 (1.4%) cases respectively. There were 5 cases of oxaliplatin dose reductions and 10 cases of doxorubicin dose reductions; 10 cycles of chemotherapy were delayed due to toxicity. Conclusions: The combination of oxaliplatin and doxorubicin showed promising efficacy in either platinum-sensitive or platinum-resistant recurrent OC. Tolerability of this regimen was acceptable.

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Abstract Details

Meeting

2011 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Gynecologic Cancer

Track

Gynecologic Cancer

Sub Track

Ovarian Cancer

Citation

J Clin Oncol 29: 2011 (suppl; abstr 5087)

Abstract #

5087

Poster Bd #

20C

Abstract Disclosures