Pembrolizumab for locally advanced and recurrent/metastatic cutaneous squamous cell carcinoma (KEYNOTE-629 study): an open-label, nonrandomized, multicenter, phase II trial.

BACKGROUND: Pembrolizumab demonstrated clinically meaningful and durable antitumor activity with a manageable safety profile in recurrent/metastatic (R/M) cutaneous squamous cell carcinoma (cSCC). PATIENTS AND METHODS: KEYNOTE-629 was a global, open-label, nonrandomized, phase II trial of patients with locally advanced (LA) or R/M cSCC conducted at 59 centers. Eligible patients received intravenous pembrolizumab 200 mg every 3 weeks for up to 35 cycles. Primary endpoint was objective response rate (ORR), defined as the percentage of patients with a complete (CR) or partial response (PR), by blinded independent central review as per Response Evaluation Criteria in Solid Tumors 1.1. Secondary endpoints included duration of response (DOR), disease control rate, progression-free survival, overall survival, and safety and tolerability. Efficacy and safety were analyzed in patients who were treated with at least one dose of pembrolizumab. RESULTS: Between 29 November 2017 and 25 September 2019, 159 patients were enrolled and treated with pembrolizumab (LA cohort, n = 54; R/M cohort, n = 105). The median time from the first dose to data cut-off date (29 July 2020) was 14.9 [interquartile range (IQR), 12.6-17.2] months for the LA cohort and 27.2 (IQR, 25.6-29.2) months for the R/M cohort. In the LA cohort, ORR was 50.0% [95% confidence interval (CI), 36.1% to 63.9%], including 16.7% of patients with a CR and 33.3% with a PR. In the R/M cohort, ORR was 35.2% (95% CI, 26.2% to 45.2%), including 10.5% of patients with a CR and 24.8% with a PR. Median DOR was not reached in either cohort. Grade 3-5 treatment-related adverse events occurred in 11.9% of patients. CONCLUSIONS: The robust antitumor activity of pembrolizumab in both LA and R/M cSCC was confirmed and demonstrated to be durable without unexpected safety signals. Our findings establish pembrolizumab as a promising treatment option for cSCC.

[Current status of frequency and complications of pelvic exenterations for recurrent cervico-uterine cancer after radiation]. / Estado actual de frecuencia y complicaciones de exenteraciones pélvicas por cáncer cervico-uterino recurrente a radiación.

Frequency and morbimortality in pelvic exenterations for cervical cancer recurrent after radiation therapy at The Oncology Service, Hospital General de México, SSA., are presented here. Between 1990 to 1994, seventy six patients with this diagnosis, were subjected to surgical exploration with the next findings: forty seven cases, (61.5%) had unresectable tumors; 29, (38.1%) were treated by exenterative procedures: Anterior exenterations, 14, (48.2%); Total exenterations, 13 (44.8%) and Posterior exenteration, 2 (6.8%). Tumor beyond pelvis was the common cause of unresectability in 34 cases, (72.2%) and periaortic lymph node metastases were related with this finding in 29 patients, (61.7%). Thirteen patients with pelvic exenterations, (44.8%) developed postoperative complications between 1 day and seven months after surgery. In seven cases, (24.1%) these complications were considered as minor complications and in six (20.6%) as major complications: Dehiscence of ureteral anastomosis, two cases, (-6.8%); ureterovaginal fistula, two (6.8%); small bowel obstruction, one (3.4%) and Chronic renal failure, one (3.4%). There were no postoperative deaths related to radical surgery in this series. It is concluded that the rate of laparotomies for cervical cancer recurrent after radiation therapy, have decreased in our Service, as compared to previous analysis as well as the rate of postoperative deaths from pelvic exenterations.