Journal of Clinical Oncology, 2005 ASCO Annual Meeting Proceedings.
Vol 23, No 16S (June 1 Supplement), 2005: 5139
© 2005 American Society of Clinical Oncology

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Abstract

Feasibility phase II study of pegylated liposomal doxorubicin (PLD) and weekly paclitaxel-carboplatin (wTC), as first line therapy for patients with advanced ovarian carcinoma suboptimally debulked

Hosp Gregorio Maranon, Madrid, Spain; Hosp de la Princesa, Madrid, Spain; H San Pedro de Alcántara, Caceres, Spain

5139

Background: This is a pilot study to evaluate the feasibility of the combination of PLD (Caelyx) and wTC, as first line therapy in patients (p) with advanced ovarian cancer suboptimally debulked (FIGO III-IV with residual disease (RD) > 1 cm). This study is a part of a whole phase II study planned to test if this regimen could achieve a pathologic complete response (pCR) rate of 25%, and a clinical overall response (cOR) rate of 80%. Methods: PLD-wTC consisted of 6 courses every 28 days of PLD 30 mg/m2 d1, Paclitaxel 60 mg/m2 d1,8,15 and Carboplatin AUC 2, d1,8,15. In addition to antiemetics, corticoids, antihistaminics and ranitidine, a single daily dose of dexametasone 8 mg p.o. d2–4 was added to reduce the risk of palmar-plantar erythrodysesthesia (PPE). Response was assessed after 6 courses or earlier in case of progressive disease. A laparotomy after PLD-wTC was planned for p with clinical complete response (cCR), and allowed in selected cases of partial response (cPR). Results: Sixteen p have been included in this feasibility part of the study. Mean age was 55 y (39–74). There were 81.2% FIGO stages IIIc and 18.8% stages IV. Debulking surgery was possible in 75% of p (in 25% only biopsy could be done), and RD larger than 2 cm was left in 81.3% of p. Histology was serous in 43.8%, mucinous 12.5% and 6.3% endometrioid. Grade 3–4 toxicities were anemia 6.3%, neutropenia 80.3% (mainly during the last 2 courses), thrombocytopenia 18.8%%, mucositis 12.5%, alopecia 62.5% and PPE 12.5%. There were no toxic deaths. Other toxicities were G1–2 or absent. After PLD-wTC, cOR was 81.3% (cCR: 31.3%, cPR: 50%). Surgery was performed in 5 p with cCR, and also in 6 p with cPR. A pCR was obtained in 2 p (12.5%, 95% CI: 1.5 - 38.3%). With a median follow-up of 25 months, 5 p have died due to their tumor, 4 p remain alive in cCR and 7 p have active disease. Median time to progression was 16 months (95% CI: 2 - 30 m). Median overall survival (OS) has not been reached; 2-year OS was 74.5% (95% CI: 52% - 97%). Conclusions: PLD-wTC is a feasible regimen. After this pilot phase, we can not yet accept or reject the planned hypothesis of efficacy (pCR and cOR rates) of the whole phase II study.

No significant financial relationships to disclose.