Anal Cancer

International Rare Cancers Initiative Multicenter Randomized Phase II Trial of Cisplatin and Fluorouracil Versus Carboplatin and Paclitaxel in Advanced Anal Cancer: InterAAct


In the July 12, 2020 edition of Journal of Clinical Oncology,  Sheela Rao and colleagues report on the results of the InterAAct trial.

PURPOSE

cisplatin plus 5-FU versus carboplatin plus paclitaxel in untreated advanced anal cancer.

PATIENTS AND METHODS

Patients with untreated advanced anal cancer, were randomized in a 1:1 fashion to IV cisplatin 60 mg/m2 (day 1) plus 5-FU 1,000 mg/m2 (days 1-4) every 3 weeks or carboplatin (AUC= 5; day 1) plus paclitaxel 80 mg/m2 (days 1, 8, and 15) every 28 days for 24 weeks, until disease progression, intolerable toxicity, or withdrawal of consent. The primary end point was ORR. Primary and secondary end points were assessed in a hierarchic model to compare the regimens.

The trial was a multicenter, international randomized phase II trial in 60 centers between December 2013 and November 2017. The median follow-up was 28.6 months. A total of 91 patients were randomly assigned: 46 to cisplatin / 5-FU and 45 to carboplatin / paclitaxel. The ORR was 57% (95% CI, 39.4% – 73.7%) for cisplatin / 5- FU versus 59% (95% CI, 42.1% – 74.4%) for carboplatin / paclitaxel. More serious adverse events were noted in the cisplatin / 5-FU arm (62%) compared with the carboplatin / paclitaxel arm (36%; P = .016). The median PFS was 5.7 months (95% CI, 3.3 – 9.0 months) for cisplatin / 5-FU compared with 8.1 months (95% CI, 6.6 to 8.8 months) for carboplatin / paclitaxel. The median OS was 12.3 months for cisplatin / 5-FU (95% CI, 9.2 to 17.7 months) compared with 20 months (95% CI, 12.7 months to not reached) for carboplatin / paclitaxel (HR, 2.00; 95% CI, 1.15 – 3.47; P = .014).

The authors concluded “This is the first international randomized trial to our knowledge conducted in chemotherapy-naïve advanced anal cancer. Although there was no difference in ORR, the association with clinically relevant reduced toxicity and a trend toward longer survival suggest that carboplatin plus paclitaxel should be considered as a new standard of care.”

Reference:

International Rare Cancers Initiative Multicenter Randomized Phase II Trial of Cisplatin and Fluorouracil Versus Carboplatin and Paclitaxel in Advanced Anal Cancer: InterAAct

https://ascopubs.org/doi/full/10.1200/JCO.19.03266

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