A Randomized Phase 3 Trial Comparing Pemetrexed/Carboplatin and Docetaxel/Carboplatin as First-Line Treatment for Advanced, Nonsquamous Non-small Cell Lung Cancer

Rodrigues-Pereira, José; Kim, Joo Hang; Magallanes, Manuel; Lee, Dong Hoon; Wang, Jie; Ganju, Vinod; Martínez-Barrera, Luis Manuel; Barraclough, Helen; Kooten, Maximiliano Van; Orlando, Mauro

doi:10.1097/jto.0b013e318226b5fa

Cited by 77 publications

(95 citation statements)

References 31 publications

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“…All the six RCTs (Hanna et al, 2004;Chen et al, 2008;Socinski et al, 2010;Rodrigues-Pereira et al, 2011;Li et al, 2012;Sun et al, 2013) reported adequate generation of the allocation sequence, but none of the studies reported allocation concealment. Four (Hanna et al, 2004;Chen et (Hanna et al, 2004;Socinski et al, 2010;RodriguesPereira et al, 2011;Sun et al, 2013) did the intent-to-treat analysis, but two (Chen et al, 2008;Li et al, 2012) of them didn't report that.…”

Section: Quality Of Included Studiesmentioning

confidence: 99%

“…All the six RCTs (Hanna et al, 2004;Chen et al, 2008;Socinski et al, 2010;Rodrigues-Pereira et al, 2011;Li et al, 2012;Sun et al, 2013) reported this outcome and 1, 400 patients were contained for this outcome (705 for pemetrexed group and 695 for docetaxel group). The rates in group pemetrexed and group docetaxel were 14.2% and 11.4% respectively.…”

Section: Overall Response Ratementioning

confidence: 99%

“…Four (Hanna et al, 2004;Chen et (Hanna et al, 2004;Socinski et al, 2010;RodriguesPereira et al, 2011;Sun et al, 2013) did the intent-to-treat analysis, but two (Chen et al, 2008;Li et al, 2012) of them didn't report that. All of the six RCTs (Hanna et al, 2004;Chen et al, 2008;Socinski et al, 2010;Rodrigues-Pereira et al, 2011;Li et al, 2012;Sun et al, 2013) reported the patients lost to follow-up in detail. Table 2 presents the specific information.…”

Section: Quality Of Included Studiesmentioning

confidence: 99%

“…Five RCTs (Hanna et al, 2004;Chen et al, 2008;Socinski et al, 2010;Rodrigues-Pereira et al, 2011;Sun et al, 2013) reported this outcome, which totally contained 1201 patients (602 for pemetrexed group and 599 for docetaxel group), two RCTs ( Hanna et al, 2004;Chen et al, 2008) (which contained 633 patients , 315 for pemetrexed group and 318 for docetaxel group) only reported this outcome without confidence interval, so they can't be summarized in the forest plot, Hanna et al, (2004) reported the median survival time was 8.3 versus 7.9 months (p =not significant) for pemetrexed and docetaxel respectively. Chen et al (Chen et al, 2008) reported that being 8.1 versus 7.7 months (p=0.871).…”

Section: Median Survival Timementioning

confidence: 99%

“…Chen et al (Chen et al, 2008) reported that being 8.1 versus 7.7 months (p=0.871). Data from the other three RCTs (Socinski et al, 2010;Rodrigues-Pereira et al, 2011;Sun et al, 2013) containing 568 patients (287 for pemetrexed group and 281 for docetaxel group), were summarized in the forest plot (See Figure 2). The heterogeneity between the three trials was p=0.148, I 2 =47.7%.…”

Section: Median Survival Timementioning

confidence: 99%

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Effectiveness and Safety of Pemetrexed Versus Docetaxel as a Treatment for Advanced Non-small Cell Lung Cancer: a Systematic Review and Meta-analysis

Wei²,

Tian³

et al. 2014

Asian Pacific Journal of Cancer Prevention

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Background: Our aim was to conduct a meta-analysis to compare the efficacy and safety of pemetrexed and docetaxel for non-small cell lung cancer (NSCLC). Materials and Methods: We systematically searched the Cochrane Library, PubMed, Embase, China Biology Medicine Database for randomized controlled trials (RCTs) comparing the efficacy and toxicities of pemetrexed versus docetaxel as a treatment for advanced NSCLC. We limited the languages to English and Chinese. Two reviewers independently screened articles to identify eligible trials according to the inclusion and exclusion criteria and assessed the methodological quality of included trials, and then extracted data. The meta-analysis was performed using STATA12.0. Results: Six RCTs involving 1,414 patients were identified. We found that there was no statistically significant differences in overall response rate, survival time, progression-free survival, disease control rate, and 1-2yr survival rate (p>0.050) but it is worthy of mention that patients in the pemetrexed arms had significantly higher 3-yr survival rate (P=0.002). With regard to the grade 3 or 4 hematological toxicity, compared with docetaxel, pemetrexed led to lower rate of grade 3-4 febrile neutropenia, neutropenia, and leukocyts toxicity (p<0.001). There was no significant difference in anemia between the two arms (p=0.08). In addition, pemetrexed led to higher rate of grade 3-4 thrombocytopenia toxicity (p=0.03). As for the non-hematological toxicities, compared with docetaxel, pemetrexed group had lower rate of grade 3-4 diarrhea and alopecia. Conclusions: Pemetrexed was almost as effective as docetaxel in patients with advanced NSCLC. At the same time, pemetrexed might increase the 3-yr survival rate. As for safety, pemetrexed led to lower rate of grade 3-4 febrile neutropenia, neutropenia, leukocytes, diarrhea and alopecia toxicity. However, it was associated with a higher rate of grade 3-4 thrombocytopenia.

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Section: Quality Of Included Studiesmentioning

confidence: 99%

Section: Overall Response Ratementioning

confidence: 99%

Section: Quality Of Included Studiesmentioning

confidence: 99%

Section: Median Survival Timementioning

confidence: 99%

Section: Median Survival Timementioning

confidence: 99%

See 3 more Smart Citations

Effectiveness and Safety of Pemetrexed Versus Docetaxel as a Treatment for Advanced Non-small Cell Lung Cancer: a Systematic Review and Meta-analysis

Wei²,

Tian³

et al. 2014

Asian Pacific Journal of Cancer Prevention

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Best first-line therapy for people with advanced non-small cell lung cancer, performance status 2 without a targetable mutation or with an unknown mutation status

Gijtenbeek,

de Jong,

Venmans

et al. 2023

Cochrane Database of Systematic Reviews

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The Pharmacoeconomic Benefits of Pemetrexed Dose Individualization in Patients With Lung Cancer

Rouw

Boer

Boosman

et al. 2022

Clin Pharma and Therapeutics

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Neutropenia is a dose-related treatment-limiting and costly adverse event of pemetrexed. We postulate that individualized dosing reduces the incidence of neutropenia. The aims of this study were (i) to investigate the costs of pemetrexed-related neutropenia and (ii) to determine the pharmacoeconomic benefits of individualized dosing of pemetrexed in terms of budget impact, yearly cost savings, and reduction in severe neutropenia. Retrospective data on the treatment of grade 3 or higher neutropenia during pemetrexed-based chemotherapy were collected from three Dutch hospitals to determine the mean healthcare consumption during a neutropenic episode. Subsequently, Monte Carlo simulations were performed using a validated pharmacokinetic/pharmacodynamic model to predict the neutropenia incidence during four cycles for standard dosing of pemetrexed and individualized dosing. The mean costs per neutropenia and the expected neutropenia incidence were combined to calculate the budget impact and cost savings. We found that the average costs per pemetrexed-associated neutropenic episode to be €1,490 (US $1,674). The neutropenia incidence for the standard and individualized pemetrexed dosing strategies were 12.7% and 9.9%, respectively. This resulted in total expected neutropenia-related costs of ~ €3.0 million (US $3.372 million) and €2.4 million (US $2.697 million), respectively. Taking the number of patients eligible for pemetrexed treatment into account, individualized dosing could result in saving €686,000 (US $770,995) on a yearly basis in the Netherlands alone. Individualized dosing of pemetrexed can decrease the incidence of neutropenia and thus result in a significant decrease in neutropenia-related costs and decreased risk of hospitalization or even death while maintaining therapeutic exposure.

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A Randomized Phase 3 Trial Comparing Pemetrexed/Carboplatin and Docetaxel/Carboplatin as First-Line Treatment for Advanced, Nonsquamous Non-small Cell Lung Cancer

Abstract: The favorable benefit-to-risk profile of pemetrexed/carboplatin suggests that pemetrexed/carboplatin is an appropriate first-line treatment option for chemonaïve patients with advanced, nonsquamous non-small cell lung cancer.

Cited by 77 publications

References 31 publications

Effectiveness and Safety of Pemetrexed Versus Docetaxel as a Treatment for Advanced Non-small Cell Lung Cancer: a Systematic Review and Meta-analysis

Effectiveness and Safety of Pemetrexed Versus Docetaxel as a Treatment for Advanced Non-small Cell Lung Cancer: a Systematic Review and Meta-analysis

Best first-line therapy for people with advanced non-small cell lung cancer, performance status 2 without a targetable mutation or with an unknown mutation status

The Pharmacoeconomic Benefits of Pemetrexed Dose Individualization in Patients With Lung Cancer

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