Trial Outcomes & Findings for Tetracycline as a Prophylaxis for Rash in Patients With NSCLC Receiving Treatment With BIBW2992 (Afatinib) (NCT NCT01880515)

Results Overview

Sum of participants who experienced any grade rash according to the Common Toxicity Criteria for Adverse Effects (CTCAE) V4.0, from the initiation of BIBW2992 compared to week 8.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

107 participants

Primary outcome timeframe

Percentage of adverse events at week 8

Results posted on

2025-05-11

Participant Flow

Participant milestones

Participant milestones
Measure	Tetracycline Patients will receive tetracycline 250mg every 12 hours for 1 month plus general dermatological recommendations (sunscreen and emollient cream) Tetracycline: The experimental group will receive tetracycline 250mg every 12 hours for 1 month the same day at initiation of BIBW2992 (afatinib)	No Tetracycline This arm only with general dermatologic recommendations. Patients in this arm can receive tetracycline after week 4 of assessment only if rash grade 3-4 occur
Overall Study STARTED	53	54
Overall Study COMPLETED	45	45
Overall Study NOT COMPLETED	8	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Tetracycline Patients will receive tetracycline 250mg every 12 hours for 1 month plus general dermatological recommendations (sunscreen and emollient cream) Tetracycline: The experimental group will receive tetracycline 250mg every 12 hours for 1 month the same day at initiation of BIBW2992 (afatinib)	No Tetracycline This arm only with general dermatologic recommendations. Patients in this arm can receive tetracycline after week 4 of assessment only if rash grade 3-4 occur
Overall Study Lost to Follow-up	3	2
Overall Study Disease Progression	5	7

Baseline Characteristics

Tetracycline as a Prophylaxis for Rash in Patients With NSCLC Receiving Treatment With BIBW2992 (Afatinib)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tetracycline n=45 Participants Patients will receive tetracycline 250mg every 12 hours for 1 month plus general dermatological recommendations Tetracycline: The experimental group will receive tetracycline 250mg every 12 hours for 1 month the same day at initiation of BIBW 2992	No Tetracycline n=45 Participants This arm only with general dermatologic recommendations. Patients in this arm can receive tetracycline after week 4 of assessment only if rash grade 3-4 occur	Total n=90 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Age, Categorical >=65 years	33 Participants n=5 Participants	33 Participants n=7 Participants	66 Participants n=5 Participants
Age, Continuous	57.5 years STANDARD_DEVIATION 14 • n=5 Participants	56.6 years STANDARD_DEVIATION 14 • n=7 Participants	57.05 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	33 Participants n=7 Participants	66 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Region of Enrollment Mexico	45 participants n=5 Participants	45 participants n=7 Participants	90 participants n=5 Participants

PRIMARY outcome

Timeframe: Percentage of adverse events at week 8

Population: Forty five patients were assigned to receive reactive treatment; the other 45 received pre-emptive tetracycline.There were no differences among demographics, disease stage and dermatological baseline characteristics between treatment groups.

Sum of participants who experienced any grade rash according to the Common Toxicity Criteria for Adverse Effects (CTCAE) V4.0, from the initiation of BIBW2992 compared to week 8.

Outcome measures

Outcome measures
Measure	Tetracycline n=45 Participants Patients will receive tetracycline 250mg every 12 hours for 1 month plus general dermatological recommendations (sunscreen and emollient cream) Tetracycline: The experimental group will receive tetracycline 250mg every 12 hours for 1 month the same day at initiation of BIBW 2992	No Tetracycline n=45 Participants This arm only with general dermatologic recommendations. Patients in this arm can receive tetracycline after week 4 of assessment only if rash grade 3-4 occur
Frequency of Participants Who Experienced Any Grade of Rash As Characterized By The Common Toxicity Criteria for Adverse Effects (CTCAE) V4.0	44.5 Percentage of Patients w/any grade rash	75.5 Percentage of Patients w/any grade rash

SECONDARY outcome

Timeframe: from baseline to 6 months

A QoL questionnaire from European Organization for Research and Treatment of Cancer (EORTC) organization (Spanish version) will be performed at initiation of BIBW 2992 and then every month of follow-up until progression

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks from baseline

The measure will be from the start of consumption to the first documented evidence of progression according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, or if patients still survive the measure will be made after 24 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Participants will be followed for the duration of the treatment, an average of 8 weeks.

Population: We estimated the progression free survival with the Kaplan Meier method, and comparisons among groups were performed with the log-rank test.

From the start of consumption of BIBW 2992 to the date progression or last follow up

Outcome measures

Outcome measures
Measure	Tetracycline n=45 Participants Patients will receive tetracycline 250mg every 12 hours for 1 month plus general dermatological recommendations (sunscreen and emollient cream) Tetracycline: The experimental group will receive tetracycline 250mg every 12 hours for 1 month the same day at initiation of BIBW 2992	No Tetracycline n=45 Participants This arm only with general dermatologic recommendations. Patients in this arm can receive tetracycline after week 4 of assessment only if rash grade 3-4 occur
Progression Free Survival	8.1 months Interval 1.7 to 14.3	12.3 months Interval 7.1 to 17.5

Adverse Events

Tetracycline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Tetracycline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Oscar Gerardo Arrieta Rodriguez

Instituto Nacional de Cancerología de México

Phone: +52 1 55 56 28 04 00

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place