Real-World Effectiveness of Afatinib (Gilotrif) Following Immunotherapy in the Treatment of Metastatic, Squamous Cell Carcinoma of the Lung: A Multi-Site Retrospective Chart Review Study in the U.S.

Primary outcomes

1. Objective Response Rate (ORR): Based on Charted/Physician-reported Disease Response

   Time frame: From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days.

   ORR was defined as the percentage of patients with a complete response (CR) or partial response (PR) out of all patients (CR+PR/all patients) at initial response assessment and best response (response based on the scan where the patient showed the best response to treatment (not progression)).

   Charted/physician-reported (physician-provided information as recorded in patient's chart) ORR is reported.

2. Objective Response Rate (ORR): Based on Lesion Measurements and RECIST v1.1 Criteria

   Time frame: From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days.

   ORR based on lesion measurements and RECIST v1.1 criteria is reported. ORR was defined as the percentage of patients with a complete response (CR) or partial response (PR) out of all patients (CR+PR/all patients) at initial response assessment and best response.

   Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1):

   CR: Disappearance of all target lesions or disappearance of all non-target lesions.

   PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

3. Duration of Objective Response (DOR)

   Time frame: From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days.

   DOR was defined as the time from initial response (for any patient with a complete or partial response initially) until the earliest of either disease progression or death. Duration of response is reported for those patients who had a complete or partial response according to charted/physician-reported disease response. Patients who discontinued therapy due to a reason other than progression were censored on the date of discontinuation. Patients still on therapy at the time of data cut-off were censored on their last visit date.

4. Duration of Clinical Benefit (DOCB)

   Time frame: From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days.

   DOCB was defined as the time from initial response (for any patient with a complete, partial, or stable disease response initially) until the earliest of either disease progression or death. DOCB reported for those patients who had a complete, partial or response according to charted/physician-reported disease response. Patients who discontinued therapy due to a reason other than progression were censored on the date of discontinuation.

   Patients still on therapy at the time of data cut-off were censored on their last visit date.

5. Progression Free Survival (PFS)

   Time frame: From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days.

   PFS was defined as time from initiation of a line of therapy until disease progression or death; patients on therapy at the time of data cut-off were censored on the last date of treatment. Patients who discontinued a line of therapy for a reason other than disease progression but who subsequently die prior to the receipt of any other therapy were considered an event on the date of death.

   Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1):

   Progressive disease (PD): at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study), or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 millimeter (mm).

6. Time on Treatment (TOT)

   Time frame: From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days.

   TOT was defined as time from initiation of a line of therapy until discontinuation for any reason. Patients on therapy at the time of data cut-off were censored on the last date of treatment.

7. Time to Progression (TTP)

   Time frame: From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days.

   TTP was defined as time from initiation of a line of therapy until discontinuation due to disease progression. Patients on therapy or those who discontinued due to a reason other than disease progression were censored on the last date of treatment.

8. Overall Survival (OS)

   Time frame: From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days.

   OS was defined as time from initiation of any therapy in the metastatic setting until death. Patients alive at the time of data cut-off were censored on the last date the patient was seen by the provider/clinic.

9. Number of Patients Who Experienced Any ADRs During Index Treatment Line

   Time frame: From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days.

   Number of patients who experienced any averse drug reactions (ADRs) during index treatment line is reported.

   An ADR was defined as a response to a medicinal product which is noxious and unintended. Response in this context means that a causal relationship between a medicinal product and an adverse event (AE) is at least a reasonable possibility.