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5 juli 2020: Bron: Clinical Oncology

Immuuntherapie met het anti-PD medicijn pembrolizumab geeft alsnog bij patiënten met uitgezaaide gevorderde baarmoederhalskanker (N = 98) waarbij chemotherapie niet voldoende effectief was en er toch weer een recidief of progressie van de ziekte ontstond, alsnog een aantal gedeeltelijke remissies (PR = 9) en complete remissies. (CR = 3). Wel blijkt achteraf dat de 12 remissies alleen optraden bij die patiënten die een zogeheten positieve PD-L1 mutatie hadden. De remissies bleken wel redelijk duurzaam want bij opmaken van de resultaten was mediane duur nog niet bereikt (range, ≥ 3.7 to ≥ 18.6 maanden).

Het volledige studierapport met alle details: Efficacy and Safety of Pembrolizumab in Previously Treated Advanced Cervical Cancer: Results From the Phase II KEYNOTE-158 Study is gratis in te zien.

Dus beperk me tot het vermelden van het abstract met daaronder aantal gerelateerde artikelen en referentielijst:

Clinical Trial
 
. 2019 Jun 10;37(17):1470-1478.
 doi: 10.1200/JCO.18.01265. Epub 2019 Apr 3.

Efficacy and Safety of Pembrolizumab in Previously Treated Advanced Cervical Cancer: Results From the Phase II KEYNOTE-158 Study

Affiliations 

Abstract

Purpose: KEYNOTE-158 ( ClinicalTrials.gov identifier: NCT02628067) is a phase II basket study investigating the antitumor activity and safety of pembrolizumab in multiple cancer types. We present interim results from patients with previously treated advanced cervical cancer.

Patients and methods: Patients received pembrolizumab 200 mg every 3 weeks for 2 years or until progression, intolerable toxicity, or physician or patient decision. Tumor imaging was performed every 9 weeks for the first 12 months and every 12 weeks thereafter. The primary end point was objective response rate (ORR), assessed per Response Evaluation Criteria in Solid Tumors (version 1.1) by independent central radiologic review. Safety was a secondary end point.

Results: Ninety-eight patients were treated. Median age was 46.0 years (range, 24 to 75 years), and 65.3% of patients had Eastern Cooperative Oncology Group performance status of 1. Eighty-two patients (83.7%) had programmed death-ligand 1 (PD-L1)-positive tumors (combined positive score ≥ 1), 77 having previously received one or more lines of chemotherapy for recurrent or metastatic disease. Median follow-up was 10.2 months (range, 0.6 to 22.7 months). ORR was 12.2% (95% CI, 6.5% to 20.4%), with three complete and nine partial responses. All 12 responses were in patients with PD-L1-positive tumors, for an ORR of 14.6% (95% CI, 7.8% to 24.2%); 14.3% (95% CI, 7.4% to 24.1%) of these responses were in those who had received one or more lines of chemotherapy for recurrent or metastatic disease. Median duration of response was not reached (range, ≥ 3.7 to ≥ 18.6 months). Treatment-related adverse events occurred in 65.3% of patients, and the most common were hypothyroidism (10.2%), decreased appetite (9.2%), and fatigue (9.2%). Treatment-related grade 3 to 4 adverse events occurred in 12.2% of patients.

Conclusion: Pembrolizumab monotherapy demonstrated durable antitumor activity and manageable safety in patients with advanced cervical cancer. On the basis of these results, the US Food and Drug Administration granted accelerated approval of pembrolizumab for patients with advanced PD-L1-positive cervical cancer who experienced progression during or after chemotherapy.

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