lunes, 16 de mayo de 2016

Non-Small Cell Lung Cancer Treatment (PDQ®)—Health Professional Version - National Cancer Institute

Non-Small Cell Lung Cancer Treatment (PDQ®)—Health Professional Version - National Cancer Institute





National Cancer Institute

Non-Small Cell Lung Cancer Treatment (PDQ®)–Health Professional Version

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Changes to This Summary (05/11/2016)

The PDQ cancer information summaries are reviewed regularly and updated as new information becomes available. This section describes the latest changes made to this summary as of the date above.
Revised text to state that in an open-label, randomized, phase III trial (LUX-Lung 3), Asian and white patients with stage IIIB/IV NSCLC and confirmed EGFR mutations were screened, and 340 patients received at least one dose of study medication for first-line treatment.
Added text to state that the assessment of overall survival (OS) was a secondary endpoint and was reported separately (cited Yang et al. as reference 46). Also added that similar to the progression-free survival (PFS) analysis, OS was stratified based on EGFR-mutation type and ethnic origin. Added OS statistics about a median follow-up of 41 months, showing that survival did not differ significantly in patients harboring common EGFR mutations. Added that prespecified subgroup analyses demonstrated a survival advantage with afatinib compared with chemotherapy in patients with tumors harboring the EGFR del19 mutation, but no significant difference was demonstrated between treatment arms in patients with tumors harboring the L858R mutation. Added that first-line afatinib was associated with a significant survival advantage compared with chemotherapy in patients with NSCLC-harboring EGFR del19 mutations but not in patients with EGFR L858R mutations or in the overall EGFR-mutation-positive patient population (added level of evidence 1iiA).
Added text to state that in an open-label, randomized, phase III trial (LUX-Lung 6), the assessment of OS was a prespecified secondary endpoint and was reported separately. Also added that similar to the PFS analysis, OS was stratified based on EGFR-mutation type and ethnic origin. Added OS statistics about a median follow-up of 33 months and the differences in the afatinib arm versus the chemotherapy arm. Added that in patients harboring common EGFR mutations, survival did not differ significantly between treatment arms. Added that prespecified subgroup analyses demonstrated a survival advantage with afatinib compared with chemotherapy in patients with tumors harboring the EGFR del19 mutation but no significant difference between treatment arms in patients with tumors harboring the L858R mutation. Added that first-line afatinib was associated with a significant survival advantage compared with chemotherapy in patients with NSCLC-harboring EGFR del19 mutations but not in patients with EGFR L858R mutations or in the overall EGFR-mutation-positive patient population (cited level of evidence 1iiA).
Listed an additional treatment option to include afatinib, as compared with erlotinib, for second-line treatment in patients with advanced squamous cell carcinoma (cited Soria et al. as reference 12).
Added text to state that afatinib, an irreversible inhibitor of the ErbB-family of receptors, has been compared with erlotinib as second-line treatment in patients with advanced squamous cell carcinoma.
Added text to state that in a randomized, controlled, phase III trial (LUX-Lung 8), patients with stage IIIB/IV squamous cell NSCLC with disease progression after frontline platinum-based chemotherapy were randomly assigned in a 1:1 ratio to receive afatinib or erlotinib. Also added that the primary endpoint was PFS and included statistics about the median follow-up. Added that secondary endpoints included OS, which was reviewed at 6-month increments to show median follow-up from 6 months to 18 months and favored the afatinib arm; the response rate showed no significant difference between the two arms. Added that the frequency of grade 3 or higher adverse events was similar between the two groups, grade 3 treatment-related diarrhea and stomatitis occurred more frequently with afatinib, and grade 3 rash or acne were more common in patients with erlotinib. The data from this study provide another option for the second-line treatment of patients with stage IIIB/IV squamous cell NSCLC.
This summary is written and maintained by the PDQ Adult Treatment Editorial Board, which is editorially independent of NCI. The summary reflects an independent review of the literature and does not represent a policy statement of NCI or NIH. More information about summary policies and the role of the PDQ Editorial Boards in maintaining the PDQ summaries can be found on the About This PDQ Summary and PDQ® - NCI's Comprehensive Cancer Database pages.

1 comentario:

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