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Annals of Oncology
therapy reduced incidence of grade 2 or higher skin toxicities compared to reactive
treatment. Prophylactic treatment resulted in skin toxicity incidence of 29%
compared with 62% in the reactive treatment arm.
Purpose: The aim of this study was to evaluate the efficacy of combination
prophylactic therapy with topical adapalene and oral minocycline in patients
receiving Pmab.
Methods: Patients with KRAS wild-type unresectable/recurrent colorectal cancer
enrolled in a prospective phase II clinical trial of third-line Pmab plus irinotecan
(CPT-11) or Pmab monotherapy were included. Prophylactic therapy with
topical adapalene, a third-generation topical retinoid used in the treatment of
mild-to-moderate acne, and oral minocycline were started from one day prior to
the first Pmab dose and continued for 6 weeks. Adapalene was administered
once daily in the evening, along with oral minocycline 100 mg twice per day.
Skin toxicity was evaluated according to NCI CTCAE, version 4. The primary
endpoint was incidence of grade 2 or higher skin toxicities during the 6-week
skin treatment period.
Results: Between January 2011 and December 2011, 48 patients were included in this
study (27 men, 21 women; median age, 62.0 years; 43 CPT-11 + Pmab, 5 Pmab
alone). During the 6 weeks of prophylactic therapy, incidence of skin toxicities (rash,
dry skin, and paronychia) was 83.3%. The incidence of skin toxicities of grade 2 or
higher was 29.2%, similar to STEPP trial results (29%). The median adherence to
topical adapalene was 90% (range, 0-100%), while minocycline was 100% (range,
17-100%). In the good adapalene adherence group (≥median), the incidence of skin
toxicity of grade 2 or higher was 20.8% compared to 37.5% in the poor adherence
group (