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-Paclitaxel-Based Therapy in Underserved Patient Populations: The ABOUND.PS2 Study in Patients With NSCLC and a Performance Status of 2

Overview
Journal Front Oncol
Specialty Oncology
Date 2018 Aug 9
PMID 30087850
Citations 7
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Abstract

Introduction: The phase II ABOUND.PS2 study (NCT02289456) assessed safety/tolerability of a first-line modified -paclitaxel/carboplatin regimen for patients with advanced non-small cell lung cancer (NSCLC) and Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2.

Methods: Chemotherapy-naive patients with stage IIIB/IV NSCLC and ECOG PS 2 received four cycles of -paclitaxel 100 mg/m days 1 and 8 plus carboplatin area under the curve 5 day 1 q3w (induction). Patients without progression received -paclitaxel monotherapy (100 mg/m days 1 and 8 q3w) until progression/unacceptable toxicity. Primary endpoint: percentage of patients discontinuing induction due to treatment-emergent adverse events (TEAEs).

Results: 11/40 treated patients (27.5%; 95% CI, 14.60-43.89) discontinued chemotherapy induction due to TEAEs; 16/40 (40.0%) continued -paclitaxel monotherapy. Median progression-free and overall survival were 4.4 (95% CI, 2.99-7.00) and 7.7 (95% CI, 4.93-13.17) months. Grade 3/4 TEAEs during induction included neutropenia (22.5%), anemia (17.5%), thrombocytopenia (5.0%), and peripheral neuropathy (2.5%).

Conclusion: This -paclitaxel-based regimen was tolerable in patients with advanced NSCLC and ECOG PS 2, with efficacy comparable to historical chemotherapy data.

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References
1.
Kosmidis P, Dimopoulos M, Syrigos K, Nicolaides C, Aravantinos G, Boukovinas I . Gemcitabine versus gemcitabine-carboplatin for patients with advanced non-small cell lung cancer and a performance status of 2: a prospective randomized phase II study of the Hellenic Cooperative Oncology Group. J Thorac Oncol. 2007; 2(2):135-40. View

2.
Lilenbaum R, Samuels M, Wang X, Kong F, Janne P, Masters G . A phase II study of induction chemotherapy followed by thoracic radiotherapy and erlotinib in poor-risk stage III non-small-cell lung cancer: results of CALGB 30605 (Alliance)/RTOG 0972 (NRG). J Thorac Oncol. 2014; 10(1):143-7. PMC: 4320012. DOI: 10.1097/JTO.0000000000000347. View

3.
Langer C, Li S, Schiller J, Tester W, Rapoport B, Johnson D . Randomized phase II trial of paclitaxel plus carboplatin or gemcitabine plus cisplatin in Eastern Cooperative Oncology Group performance status 2 non-small-cell lung cancer patients: ECOG 1599. J Clin Oncol. 2007; 25(4):418-23. DOI: 10.1200/JCO.2005.04.9452. View

4.
Reynolds C, Barrera D, Jotte R, Spira A, Weissman C, Boehm K . Phase II trial of nanoparticle albumin-bound paclitaxel, carboplatin, and bevacizumab in first-line patients with advanced nonsquamous non-small cell lung cancer. J Thorac Oncol. 2009; 4(12):1537-43. DOI: 10.1097/JTO.0b013e3181c0a2f4. View

5.
Langer C, OByrne K, Socinski M, Mikhailov S, Lesniewski-Kmak K, Smakal M . Phase III trial comparing paclitaxel poliglumex (CT-2103, PPX) in combination with carboplatin versus standard paclitaxel and carboplatin in the treatment of PS 2 patients with chemotherapy-naïve advanced non-small cell lung cancer. J Thorac Oncol. 2008; 3(6):623-30. DOI: 10.1097/JTO.0b013e3181753b4b. View