Phase 2 Case Of Cediranib Inwards Combination Alongside Cisplatin Together With Pemetrexed Inwards Chemotherapy-Naïve Patients Alongside Unresectable Malignant Pleural Mesothelioma (Swog S0905).

Journal of Clinical Oncology 2019 August 6 [Link]

Tsao AS, Miao J, Wistuba II, Vogelzang NJ, Heymach JV, Fossella FV, Lu C, Velasco MR, Box-Noriega B, Hueftle JG, Gadgeel S, Redman MW, Gandara DR, Kelly K

Abstract

PURPOSE:

Antiangiogenic agents combined alongside chemotherapy bring efficacy inwards the handling of unresectable malignant pleural mesothelioma (MPM). Cediranib (AstraZeneca, Cheshire, United Kingdom), a vascular endothelial growth percentage receptor in addition to platelet-derived growth percentage receptor inhibitor, demonstrated therapeutic potential inwards a prior stage I trial. We evaluated a stage II lawsuit for efficacy.

PATIENTS AND METHODS:

SWOG S0905 (ClinicalTrials.gov identifier: NCT01064648) randomly assigned cediranib or placebo alongside platinum-pemetrexed for vi cycles followed past times maintenance cediranib or placebo inwards unresectable chemotherapy-naïve patients alongside MPM of whatsoever histologic subtype. Primary terminate betoken was Response Evaluation Criteria inwards Solid Tumors (RECIST) version 1.1 progression-free survival (PFS). Secondary terminate points included overall survival, PFS past times modified RECIST v1.1, reply (modified RECIST in addition to RECIST v1.1), illness control, in addition to safety/toxicity. The lawsuit was designed to honor a deviation inwards RECIST v1.1 PFS at the one-sided 0.1 degree using a stratified log-rank test.

RESULTS:

Ninety-two eligible patients were enrolled (75% epithelioid in addition to 25% biphasic or sarcomatoid). The cediranib arm had to a greater extent than course of written report iii in addition to iv diarrhea, dehydration, hypertension, in addition to weight loss. Cediranib improved PFS past times RECIST v1.1 (hazard ratio, 0.71; 80% CI, 0.54 to 0.95; P = .062; 7.2 months v 5.6 months) in addition to increased modified RECIST v1.1 reply (50% v 20%; P = .006). By modified RECIST v1.1, cediranib numerically increased PFS (hazard ratio, 0.77; 80% CI, 0.59 to 1.02; P = .12; median, 6.9 months v5.6 months). No meaning deviation inwards overall survival was observed.

CONCLUSION:

The improver of cediranib to platinum-pemetrexed improved PFS past times RECIST v1.1 in addition to reply charge per unit of measurement past times modified RECIST inwards patients alongside unresectable MPM. Whereas adding antiangiogenics to chemotherapy has been a successful strategy for unopen to patients, the cediranib toxicity profile in addition to pocket-size incremental survival produce goodness precludes additional evolution inwards MPM.



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