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Performance status

Source: Non-Small Cell Lung Cancer Treatment (PDQ®)–Health Professional Version, National Cancer Institute.

Source updated: May 15, 2025 · Captured 2026-09-09.

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Context: Treatment of Newly Diagnosed Stage IV, Relapsed, and Recurrent NSCLC / Factors Affecting Treatment Selection

Performance status is among the most important prognostic factors for survival of patients with NSCLC.[15] The benefit of therapy for this group of patients has been evaluated through retrospective analyses and prospective clinical trials.

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The results support further evaluation of chemotherapeutic approaches for both metastatic and locally advanced NSCLC; however, the efficacy of current platinum-based chemotherapy combinations is such that no specific regimen can be regarded as standard therapy. Outside of a clinical trial setting, chemotherapy should only be given to patients with good performance status and evaluable tumor lesions, who desire this treatment after being fully informed of its anticipated risks and limited benefits.

Randomized controlled trials of patients with stage IV disease and good performance status have shown that cisplatin-based chemotherapy improves survival and palliates disease-related symptoms.[3][Level of evidence A1]

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Evidence (performance status):

The Cancer and Leukemia Group B trial (CLB-9730 [NCT00003117]), which compared carboplatin and paclitaxel with single-agent paclitaxel, enrolled 99 patients with a performance status of 2 (18% of the study's population).[13]

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The Cancer and Leukemia Group B trial (CLB-9730 [NCT00003117]), which compared carboplatin and paclitaxel with single-agent paclitaxel, enrolled 99 patients with a performance status of 2 (18% of the study's population).[13]

When compared with patients with a performance status of 0 to 1, who had a median survival of 8.8 months and a 1-year survival rate of 38%, the corresponding median survival figures for patients with a performance status of 2 were 3.0 months and a 1-year survival rate of 14%; this demonstrates the poor prognosis conferred by a lower performance status. These differences were statistically significant.

The Cancer and Leukemia Group B trial (CLB-9730 [NCT00003117]), which compared carboplatin and paclitaxel with single-agent paclitaxel, enrolled 99 patients with a performance status of 2 (18% of the study's population).[13]

When patients with a performance status of 2 were analyzed by treatment arm, those who received combination chemotherapy had a significantly higher response rate (24% vs. 10%), longer median survival (4.7 months vs. 2.4 months), and a superior 1-year survival rate (18% vs. 10%), compared with those who were treated with single-agent paclitaxel.[13]

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A phase III trial compared single-agent pemetrexed with the combination of carboplatin and pemetrexed in 205 patients with a performance status of 2 who had not had any previous chemotherapy.[16][Level of evidence A1]This study, which was performed in eight centers in Brazil and one center in the United States, reported rates of OS and PFS that were higher than has historically been noted in most, although not all, other published studies. This may indicate differences in patient selection.

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A phase III trial compared single-agent pemetrexed with the combination of carboplatin and pemetrexed in 205 patients with a performance status of 2 who had not had any previous chemotherapy.[16][Level of evidence A1]This study, which was performed in eight centers in Brazil and one center in the United States, reported rates of OS and PFS that were higher than has historically been noted in most, although not all, other published studies. This may indicate differences in patient selection.

Median OS was 5.3 months for the pemetrexed-alone group and 9.3 months for the carboplatin-and-pemetrexed group (hazard ratio [HR], 0.62; 95% confidence interval [CI], 0.46–0.83; P = .001).

A phase III trial compared single-agent pemetrexed with the combination of carboplatin and pemetrexed in 205 patients with a performance status of 2 who had not had any previous chemotherapy.[16][Level of evidence A1]This study, which was performed in eight centers in Brazil and one center in the United States, reported rates of OS and PFS that were higher than has historically been noted in most, although not all, other published studies. This may indicate differences in patient selection.

Median PFS was 2.8 months for the pemetrexed-alone group and 5.8 months for the carboplatin-and-pemetrexed group (P < .001).

A phase III trial compared single-agent pemetrexed with the combination of carboplatin and pemetrexed in 205 patients with a performance status of 2 who had not had any previous chemotherapy.[16][Level of evidence A1]This study, which was performed in eight centers in Brazil and one center in the United States, reported rates of OS and PFS that were higher than has historically been noted in most, although not all, other published studies. This may indicate differences in patient selection.

The response rates were 10.3% for the pemetrexed-alone group and 23.8% for the carboplatin-and-pemetrexed group (P = .032).

A phase III trial compared single-agent pemetrexed with the combination of carboplatin and pemetrexed in 205 patients with a performance status of 2 who had not had any previous chemotherapy.[16][Level of evidence A1]This study, which was performed in eight centers in Brazil and one center in the United States, reported rates of OS and PFS that were higher than has historically been noted in most, although not all, other published studies. This may indicate differences in patient selection.

Side effects were more frequent in the combination arm, as expected.

A subset analysis of 68 patients with a performance status of 2 from a trial that randomly assigned more than 1,200 patients to four platinum-based regimens has been published.

A subset analysis of 68 patients with a performance status of 2 from a trial that randomly assigned more than 1,200 patients to four platinum-based regimens has been published.

Despite a high incidence of adverse events, including five deaths, the final analysis showed that the overall toxic effects experienced by patients with a performance status of 2 was not significantly different from that experienced by patients with a performance status of 0 to 1.

A subset analysis of 68 patients with a performance status of 2 from a trial that randomly assigned more than 1,200 patients to four platinum-based regimens has been published.

An efficacy analysis demonstrated an overall response rate of 14%, median survival time of 4.1 months, and a 1-year survival rate of 19%; all were substantially inferior to the patients with performance status of 0 to 1.

A phase II randomized trial (E-1599 [NCT00006004]) of attenuated dosages of cisplatin plus gemcitabine and carboplatin plus paclitaxel included 102 patients with a performance status of 2.[17]

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A phase II randomized trial (E-1599 [NCT00006004]) of attenuated dosages of cisplatin plus gemcitabine and carboplatin plus paclitaxel included 102 patients with a performance status of 2.[17]

Response rates were 25% in the cisplatin-plus-gemcitabine arm and 16% in the carboplatin-plus-paclitaxel arm; median survival times were 6.8 months in the cisplatin-plus-gemcitabine arm and 6.1 months in the carboplatin-plus-paclitaxel arm; 1-year survival rates were 25% in the cisplatin-plus-gemcitabine arm and 19% in the carboplatin-plus-paclitaxel arm. None of these differences was statistically significant, but the survival figures were longer than expected, based on historical controls.

Results from two trials suggest that patients with a performance status of 2 may experience symptom improvement.[18,19]

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