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HEALTH PROFESSIONAL · SOURCE READING

Afatinib

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

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

Selected source text with whitespace normalised. This Triangle page is not an NCI PDQ summary.

Context: Treatment of Progressive Stage IV, Relapsed, and Recurrent NSCLC / Treatment Options for Progressive Stage IV, Relapsed, and Recurrent NSCLC (Second-Line Therapy) / EGFR-directed therapy / EGFR-directed therapy after first-line chemotherapy (for patients with EGFR-sensitizing variants)

Evidence (afatinib):

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. In a randomized, controlled, phase III trial (LUX-Lung 8 [NCT01523587]), 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 (398 patients, 40 mg by mouth every day) or erlotinib (397 patients, 150 mg by mouth every day).[27][Level of evidence B1] The primary end point was PFS. Secondary end points included OS and response rate.

Source links and citations

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. In a randomized, controlled, phase III trial (LUX-Lung 8 [NCT01523587]), 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 (398 patients, 40 mg by mouth every day) or erlotinib (397 patients, 150 mg by mouth every day).[27][Level of evidence B1] The primary end point was PFS. Secondary end points included OS and response rate.

After a median follow-up of 6.7 months, the PFS was 2.4 months versus 1.9 months (HR, 0.82; 95% CI, 0.68–1.00).

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. In a randomized, controlled, phase III trial (LUX-Lung 8 [NCT01523587]), 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 (398 patients, 40 mg by mouth every day) or erlotinib (397 patients, 150 mg by mouth every day).[27][Level of evidence B1] The primary end point was PFS. Secondary end points included OS and response rate.

After a median follow-up of 18.4 months, the median OS was significantly longer in the afatinib arm (7.9 months vs. 6.8 months; HR, 0.81; 95% CI, 0.69–0.95; P = .007). Survival at 6 months (63.6% vs. 54.6%; P = .009), 12 months (36.4% vs. 28.2%; P = .015), and 18 months (22% vs. 14.4%; P = .013) were all significantly better in patients who received afatinib.

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. In a randomized, controlled, phase III trial (LUX-Lung 8 [NCT01523587]), 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 (398 patients, 40 mg by mouth every day) or erlotinib (397 patients, 150 mg by mouth every day).[27][Level of evidence B1] The primary end point was PFS. Secondary end points included OS and response rate.

There was no significant difference in response rate between the two arms (6% vs. 3%; P = .551).

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. In a randomized, controlled, phase III trial (LUX-Lung 8 [NCT01523587]), 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 (398 patients, 40 mg by mouth every day) or erlotinib (397 patients, 150 mg by mouth every day).[27][Level of evidence B1] The primary end point was PFS. Secondary end points included OS and response rate.

The frequency of adverse events was similar between the two groups with 57% of the patients experiencing a rate of grade 3 or higher adverse events. Grade 3 treatment-related diarrhea and stomatitis occurred more frequently with afatinib; however, grade 3 rash or acne were more common in patients who received erlotinib.

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. In a randomized, controlled, phase III trial (LUX-Lung 8 [NCT01523587]), 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 (398 patients, 40 mg by mouth every day) or erlotinib (397 patients, 150 mg by mouth every day).[27][Level of evidence B1] The primary end point was PFS. Secondary end points included OS and response rate.

Afatinib, as compared with erlotinib, represents another option for the second-line treatment of patients with stage IV squamous cell NSCLC.

Studies cited in this source section

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Preserved source evidence · Not medical advice