|The following article features coverage from the SGO 2022 Annual Meeting on Women’s Cancer. Click here to read more of Cancer Therapy Advisor’s conference coverage.|
Intraperitoneal (IP) administration of carboplatin can prolong progression-free survival (PFS), but not overall survival (OS), in patients with ovarian cancer, according to a phase 3 study.
Researchers compared IP carboplatin and intravenous (IV) carboplatin, each in combination with IV paclitaxel, in patients with stage II to IV epithelial ovarian, fallopian tube, or primary peritoneal carcinoma who had undergone laparotomy.
The results were presented at the SGO 2022 Annual Meeting on Women’s Cancer by Keiichi Fujiwara, MD, PhD, of Saitama Medical University International Medical Center in Japan.
The phase 3 iPocc trial (ClinicalTrials.gov Identifier: NCT01506856) included 655 patients who were randomly assigned to receive IV paclitaxel plus either IV carboplatin or IP carboplatin for 6 to 8 cycles after surgery. Patients did not receive maintenance.
At baseline, the patients’ median age was 59 years. The most common site of disease was the ovary (78% in the IV arm and 74% in the IP arm), the most common histology was serous (63% and 65%, respectively), most patients had stage III disease (68% vs 69%), and most had residual disease of 2 cm or greater (56% vs 55%).
There were 602 patients deemed eligible after surgery — 299 in the IV arm and 303 in the IP arm.
PFS was significantly longer for patients who received IP carboplatin. The median PFS was 22.9 months in the IP arm and 20.0 months in the IV arm (hazard ratio [HR], 0.78; 95% CI, 0.65-0.94; P =.009). A prespecified subgroup analysis showed that the PFS benefit with the IP regimen was driven primarily by patients with greater than 2 cm of residual disease.
The OS was similar between the arms. The median OS was 64.9 months in the IP arm and 64.0 months in the IV arm (HR, 0.91; 95% CI, 0.73-1.13; P =.403). Dr Fujiwara suggested that the availability of newer agents, such as PARP inhibitors, may be a reason that improved OS was not observed with IP carboplatin.
The rate of grade 3 or higher adverse events was similar between the treatment arms — 93.2% in the IP arm and 96.0% in the IV arm.
Abdominal pain of any grade was more common with the IP regimen than with the IV regimen (51.7% and 34.7%, respectively). Catheter-related toxicities of any grade in the IP arm included catheter-related infection (10.1%), abdominal infection (2.4%), and vaginal anastomotic leak (5.7%).
Dr Fujiwara concluded that more research is needed to elucidate the role of IP carboplatin-based chemotherapy in the PARP inhibitor era and to identify biomarkers for patient selection. However, IP carboplatin-based chemotherapy may be a “strong weapon” for countries in which maintenance bevacizumab or PARP inhibitors are not available or affordable.
Disclosures: Carboplatin for IP use was provided by Bristol Meyers Squibb and Sandoz. Paclitaxel was provided, in part, by Nippon Kayaku and Sawai Pharmaceuticals. Dr Fujiwara disclosed relationships with AstraZeneca, Daiichi Sankyo, Eisai, Genmab, Kyowa Kirin, MSD, Takeda, Zeria, and Seagen.
Read more of Cancer Therapy Advisor’s coverage of SGO 2022 by visiting the conference page.
Fujiwara K, Nagao S, Yamamoto K, et al. A randomized phase 3 trial of intraperitoneal versus intravenous carboplatin with dose-dense weekly paclitaxel in patients with ovarian, fallopian tube, or primary peritoneal carcinoma (a GOTIC-001/JGOG-3019/GCIG, iPocc Trial). Presented at SGO 2022; March 18-21, 2022. Abstract LBA 3.