Incorporation of pazopanib in maintenance therapy of ovarian cancer.
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du Bois Andreas, Floquet Anne, Kim Jae-Weon, Rau Joern, del Campo Josep M, Friedlander Michael, Pignata Sandro, Fujiwara Keiichi, Vergote Ignace, Colombo Nicoletta, Mirza Mansoor R, Monk Bradley J, Kimmig Rainer, Ray-Coquard Isabelle, Zang Rongyu, Diaz-Padilla Ivan, Baumann Klaus H, Mouret-Reynier Marie-Ange, Kim Jae-Hoon, Kurzeder Christian, Lesoin Anne, Vasey Paul, Marth Christian, Canzler Ulrich, Scambia Giovanni, Shimada Muneaki, Calvert Paula, Pujade-Lauraine Eric, Kim Byoung-Gie, Herzog Thomas J, Mitrica Ionel, Schade-Brittinger Carmen, Wang Qiong, Crescenzo Rocco, Harter Philipp
Аннотация
PATIENTS AND METHODS: Nine hundred forty patients with histologically confirmed cancer of the ovary, fallopian tube, or peritoneum, International Federation Gynecology Obstetrics (FIGO) stages II-IV, no evidence of progression after primary therapy consisting of surgery and at least five cycles of platinum-taxane chemotherapy were randomized 1:1 to receive pazopanib 800 mg once per day or placebo for up to 24 months. The primary end point was progression-free survival by RECIST 1.0 assessed by the investigators.
RESULTS: Maintenance pazopanib prolonged progression-free survival compared with placebo (hazard ratio [HR], 0.77; 95% CI, 0.64 to 0.91; P = .0021; median, 17.9 v 12.3 months, respectively). Interim survival analysis based on events in 35.6% of the population did not show any significant difference. Grade 3 or 4 adverse events of hypertension (30.8%), neutropenia (9.9%), liver-related toxicity (9.4%), diarrhea (8.2%), fatigue (2.7%), thrombocytopenia (2.5%), and palmar-plantar erythrodysesthesia (1.9%) were significantly higher in the pazopanib arm. Treatment discontinuation related to adverse events was higher among patients treated with pazopanib (33.3%) compared with placebo (5.6%).
CONCLUSION: Pazopanib maintenance therapy provided a median improvement of 5.6 months (HR, 0.77) in progression-free survival in patients with advanced ovarian cancer who have not progressed after first-line chemotherapy. Overall survival data to this point did not suggest any benefit. Additional analysis should help to identify subgroups of patients in whom improved efficacy may balance toxicity (NCT00866697).