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Carboplatin plus paclitaxel in combination with bevacizumab for the treatment of adenocarcinoma with interstitial lung diseases.

ABSTRACT: Interstitial lung diseases (ILDs) are frequently associated with lung cancer. The safety of carboplatin plus paclitaxel in combination with bevacizumab (CP-B) in patients with ILD and lung cancer (ILD-LC) remains to be clarified. In the present study, the safety and efficacy of CP-B treatment in ILD-LC patients were retrospectively investigated. Four patients, who completed CP-B therapy, were included in this study. The dose of carboplatin was the area under the curve 5, paclitaxel was 200 mg/m2 and bevacizumab was 15 mg/kg at treatment initiation. The patients were males, had histologically confirmed adenocarcinoma, were smokers and demonstrated non-usual interstitial pneumonia (non-UIP) patterns on computed tomography (CT). Patients received 1-6 cycles of CP-B therapy. Three of the four patients received maintenance bevacizumab therapy for 3-10 cycles. Only one patient demonstrated a partial response. Neutropenia was the most frequent adverse event. One patient experienced gut perforation during the first course of CP-B. No pulmonary toxicity was observed. Thus, treatment of ILD-LC patients with CP-B was not associated with pulmonary toxicity, however, this study population appeared to be at a low risk.

SUBMITTER: Suzuki H

PROVIDER: S-EPMC3915637 | biostudies-other | 2013 May

REPOSITORIES: biostudies-other

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Carboplatin plus paclitaxel in combination with bevacizumab for the treatment of adenocarcinoma with interstitial lung diseases.

Suzuki Hidekazu H Hirashima Tomonori T Kobayashi Masashi M Okamoto Norio N Matsuura Yuka Y Tamiya Motohiro M Morishita Naoko N Okafuji Kohei K Shiroyama Takayuki T Morimura Osamu O Morita Satomu S Kawase Ichiro I

Molecular and clinical oncology 20130301 3

Interstitial lung diseases (ILDs) are frequently associated with lung cancer. The safety of carboplatin plus paclitaxel in combination with bevacizumab (CP-B) in patients with ILD and lung cancer (ILD-LC) remains to be clarified. In the present study, the safety and efficacy of CP-B treatment in ILD-LC patients were retrospectively investigated. Four patients, who completed CP-B therapy, were included in this study. The dose of carboplatin was the area under the curve 5, paclitaxel was 200 mg/m< ...[more]

PMID: 24649195

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Project description:BACKGROUND:BTH1677, a beta-glucan pathogen-associated molecular pattern molecule, drives an anti-cancer immune response in combination with oncology antibody therapies. This phase II study explored the efficacy, pharmacokinetics (PK), and safety of BTH1677 combined with bevacizumab/carboplatin/paclitaxel in patients with untreated advanced non-small cell lung cancer (NSCLC). METHODS:Patients were randomized to the BTH1677 arm (N?=?61; intravenous [IV] BTH1677, 4 mg/kg, weekly; IV bevacizumab, 15 mg/kg, once each 3-week cycle [Q3W]; IV carboplatin, 6 mg/mL/min Calvert formula area-under-the-curve, Q3W; and IV paclitaxel, 200 mg/m2, Q3W) or Control arm (N?=?31; bevacizumab/carboplatin/paclitaxel as above). Carboplatin/paclitaxel was discontinued after 4-6 cycles and patients who responded or remained stable received maintenance therapy with BTH1677/bevacizumab (BTH1677 arm) or bevacizumab (Control arm). Efficacy assessments, based on blinded central radiology review, included objective response rate (ORR; primary endpoint), disease control rate, duration of objective response, and progression-free survival. Overall survival and adverse events (AEs) were also assessed. RESULTS:ORR was higher in the BTH1677 vs Control arm but the difference between groups was not statistically significant (60.4% vs 43.5%; P?=?.2096). All other clinical endpoints also favored the BTH1677 arm but none statistically differed between arms. PK was consistent with previous studies. Although a higher incidence of Grade 3/4 AEs occurred in the BTH1677 vs Control arm (93.2% vs 66.7%), no unexpected AEs were observed. Serious AEs and discontinuations due to AEs were lower in the BTH1677 vs Control arm. CONCLUSIONS:Improvements in tumor assessments and survival were observed with BTH1677/bevacizumab/carboplatin/paclitaxel compared with control treatment in patients with advanced NSCLC. TRIAL REGISTRATION:ClinicalTrials.gov registration ID: NCT00874107 . Registered 2 April 2009. First participant was enrolled on 29 September 2009.

Project description:BackgroundPF-06439535 is a bevacizumab biosimilar. We aimed to compare the efficacy and safety of PF-06439535 with that of reference bevacizumab (Avastin®) sourced from the EU (bevacizumab-EU), each with paclitaxel and carboplatin, in the first-line treatment of advanced non-squamous non-small-cell lung cancer (NSCLC).MethodsIn this double-blind, parallel-group study, we recruited patients from 159 centers in 27 countries. Participants were randomized 1:1 to receive PF-06439535 plus paclitaxel and carboplatin or bevacizumab-EU plus paclitaxel and carboplatin on day 1 of each 21-day cycle for 4-6 cycles, followed by blinded monotherapy with PF-06439535 or bevacizumab-EU until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study. Randomization was stratified by region, sex, and smoking history. The primary endpoint was objective response rate (ORR) in accordance with RECIST 1.1, based on responses achieved by week 19 and confirmed by week 25.ResultsBetween 21 May 2015 and 14 November 2016, 719 patients were randomized to the PF-06439535 group (n = 358) or the bevacizumab-EU group (n = 361). As of data cutoff for analysis of the primary endpoint (8 May 2017), 45.3% (95% confidence interval [CI] 40.01-50.57) of patients in the PF-06439535 group and 44.6% (95% CI 39.40-49.89) of patients in the bevacizumab-EU group achieved an objective response by week 19 that was confirmed by week 25. The unstratified ORR risk ratio was 1.015 (95% CI 0.863-1.193; 90% CI 0.886-1.163), and the unstratified ORR risk difference was 0.653% (95% CI - 6.608 to 7.908); all three CIs fell within pre-specified equivalence margins. Using final data after study completion (22 December 2017), no notable differences in progression-free survival or overall survival were observed between the groups. The most frequently reported grade 3 or higher treatment-emergent adverse events were hypertension, neutropenia, and anemia. There were no clinically meaningful differences in safety, pharmacokinetics, or immunogenicity across treatment groups.ConclusionAmong patients with advanced non-squamous NSCLC, PF-06439535 demonstrated similarity to bevacizumab-EU in terms of efficacy. Safety profiles for the two treatments were comparable.Trial registrationClinicalTrials.gov, NCT02364999.FundingPfizer.

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Carboplatin plus paclitaxel in combination with bevacizumab for the treatment of adenocarcinoma with interstitial lung diseases.

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Carboplatin plus paclitaxel in combination with bevacizumab for the treatment of adenocarcinoma with interstitial lung diseases.

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