Randomized Phase III Trial of Single-Agent Pemetrexed Versus Carboplatin and Pemetrexed in Patients With Advanced Non–Small-Cell Lung Cancer and Eastern Cooperative Oncology Group Performance Status of 2

Zukin, Mauro; Barrios, Carlos H.; Pereira, José Rodrígues; Ribeiro, Ronaldo de Albuquerque; Beato, Carlos Augusto de Mendonça; Nascimento, Yeni Neron do; Murad, André M.; Franke, Fábio; Precivale, Maristela; Araujo, Luiz H.; Baldotto, Clarissa; Vieira, Fernando Meton de Alencar Câmara; Small, I. A.; Ferreira, Carlos Gil; Lilenbaum, Rogério

doi:10.1200/jco.2012.48.1911

Cited by 206 publications

(166 citation statements)

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“…The results of these trials suggest that platinum-based combination regimens are superior to singleagent chemotherapy in the first-line treatment of this special population both in terms of ORR and 1y-SR, despite an increase in severe haematological toxicities. This literature-based meta-analysis confirms the results achieved in the randomized trials devoted to PS 2 patients [18,19].…”

Section: Discussionsupporting

confidence: 85%

“…Five publications [18,19,[21][22][23] are about randomized phase III trials and one was a randomized phase II trial [24]. Four studies [18,19,21,24] were specifically devoted to PS2 patients, while two trials [22,25] reported subgroup analysis for PS2 patients (18 and 20%, respectively) within larger randomized phase III trials.…”

Section: Resultsmentioning

confidence: 99%

“…Four studies [18,19,21,24] were specifically devoted to PS2 patients, while two trials [22,25] reported subgroup analysis for PS2 patients (18 and 20%, respectively) within larger randomized phase III trials. All trials compared a platinumbased doublet with single-agent chemotherapy; four of these [18,21,22,24] compared carboplatin-based doublet with single agent chemotherapy: carboplatin plus pemetrexed vs pemetrexed alone [18], carboplatin plus gemcitabine vs gemcitabine alone [21,24], carboplatin plus paclitaxel vs paclitaxel alone [22,25]; the other two trials compared cisplatin plus gemcitabine with gemcitabine alone [19] and cisplatin plus vinorelbine or vindesine with vinorelbine alone [23]. In nearly every trial characteristics were well balanced between two arms.…”

Section: Resultsmentioning

confidence: 99%

“…The extracted data, including number of patients, PS, age, histology, stage, chemotherapy regimens, and outcomes, were reported in Table 2. Data about ORR [18,19,21,22,24] and 1y-SR [18,[21][22][23][24] were available from five studies. Finally, data about toxicity were available from 4 trials [18,19,21,24].…”

Section: Resultsmentioning

confidence: 99%

“…However, in the last years, new prospective randomized phase III trials have been performed to evaluate the efficacy and tolerability of platinum-based doublet chemotherapy compared to single agent in this subset of patients, revealing unexpected results [18,19].…”

Section: Introductionmentioning

confidence: 99%

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What can platinum offer yet in the treatment of PS2 NSCLC patients? A systematic review and meta-analysis

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Critical Reviews in Oncology/Hematology

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Section: Discussionsupporting

confidence: 85%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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What can platinum offer yet in the treatment of PS2 NSCLC patients? A systematic review and meta-analysis

Bronte

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et al. 2015

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Systemic Therapy for Locally Advanced and Metastatic Non–Small Cell Lung Cancer

Arbour

Riely

2019

JAMA

785

620

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IMPORTANCE Non-small cell lung cancer remains the leading cause of cancer death in the United States. Until the last decade, the 5-year overall survival rate for patients with metastatic non-small cell lung cancer was less than 5%. Improved understanding of the biology of lung cancer has resulted in the development of new biomarker-targeted therapies and led to improvements in overall survival for patients with advanced or metastatic disease.OBSERVATIONS Systemic therapy for metastatic non-small cell lung cancer is selected according to the presence of specific biomarkers. Therefore, all patients with metastatic non-small cell lung cancer should undergo molecular testing for relevant mutations and expression of the protein PD-L1 (programmed death ligand 1). Molecular alterations that predict response to treatment (eg, EGFR mutations, ALK rearrangements, ROS1 rearrangements, and BRAF V600E mutations) are present in approximately 30% of patients with non-small cell lung cancer. Targeted therapy for these alterations improves progression-free survival compared with cytotoxic chemotherapy. For example, somatic activating mutations in the EGFR gene are present in approximately 20% of patients with advanced non-small cell lung cancer. Tyrosine kinase inhibitors such as gefitinib, erlotinib, and afatinib improve progression-free survival in patients with susceptible EGFR mutations. In patients with overexpression of ALK protein, the response rate was significantly better with crizotinib (a tyrosine kinase inhibitor) than with the combination of pemetrexed and either cisplatin or carboplatin (platinum-based chemotherapy) (74% vs 45%, respectively; P < .001) and progression-free survival (median, 10.9 months vs 7.0 months; P < .001). Subsequent generations of tyrosine kinase inhibitors have improved these agents. For patients without biomarkers indicating susceptibility to specific targeted treatments, immune checkpoint inhibitor-containing regimens either as monotherapy or in combination with chemotherapy are superior vs chemotherapy alone. These advances in biomarker-directed therapy have led to improvements in overall survival. For example, the 5-year overall survival rate currently exceeds 25% among patients whose tumors have high PD-L1 expression (tumor proportion score of Ն50%) and 40% among patients with ALK-positive tumors.CONCLUSIONS AND RELEVANCE Improved understanding of the biology and molecular subtypes of non-small cell lung cancer have led to more biomarker-directed therapies for patients with metastatic disease. These biomarker-directed therapies and newer empirical treatment regimens have improved overall survival for patients with metastatic non-small cell lung cancer.

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Development and Application of a Machine Learning Approach to Assess Short-term Mortality Risk Among Patients With Cancer Starting Chemotherapy

et al. 2018

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Randomized Phase III Trial of Single-Agent Pemetrexed Versus Carboplatin and Pemetrexed in Patients With Advanced Non–Small-Cell Lung Cancer and Eastern Cooperative Oncology Group Performance Status of 2

Abstract: Combination chemotherapy with CP significantly improves survival in patients with advanced NSCLC and ECOG PS of 2.

Cited by 206 publications

References 5 publications

What can platinum offer yet in the treatment of PS2 NSCLC patients? A systematic review and meta-analysis

What can platinum offer yet in the treatment of PS2 NSCLC patients? A systematic review and meta-analysis

Systemic Therapy for Locally Advanced and Metastatic Non–Small Cell Lung Cancer

Development and Application of a Machine Learning Approach to Assess Short-term Mortality Risk Among Patients With Cancer Starting Chemotherapy

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