Abstract 488P
Background
Acneiform rash as an adverse event often affects the treatment by EGFR-TKIs. Since minocycline has been suggested to reduce the rash, we assessed the efficacy and safety of prophylactic administration of minocycline simultaneously during erlotinib treatment.
Methods
Patients of ECOG performance status 0-2 with advanced NSCLC, who had not been treated with EGFR-TKIs and would receive erlotinib treatment were randomized 1:1 into either group A, with minocycline or group B, without minocycline. The patients assigned to group A were started on minocycline 100mg/day orally for 8 weeks with erlotinib. Primary end point was the frequency of grade ≥2 rash acneiform by independent assessment in first 8 weeks. We expected the prophylactic minocycline decreased the incidence of grade ≥2 skin rash from 50% to 30%. The planned sample size was 280 patients with a = 0.025 (one-sided) and b = 0.10.
Results
Patients accrual was started in March 2015 and ended in June 2018 because of slow accrual. Ninety-four patients were finally enrolled and 93 were full-analysis set. The median age of the patients was 71 years old (range 45 to 89),58 patients were female. EGFR mutation status positive/negative/unknown=78/13/2 patients. The frequency of grade ≥2 rash acneiformby independent assessment was 33.3% [95%C.I. 20.0-49.0%] in group A vs. 44.2% [95%C.I. 29.1-60.1%] in group B (p = 0.296). The frequency by physicians’ evaluation was 31.3% [95%C.I. 18.7-48.8%] and 45.5% [95%C.I. 30.4-61.2%] (p = 0.161). However, the frequency of grade ≥2 rash acneiform on day 15 by physicians’ evaluation was significantly decreased (4.4% [95%C.I. 5.3-14.8%] in group A vs. 25.0% [95%C.I. 13.2-40.3%] in group B (p = 0.005)). As for toxicity, the incidence of any grade skin-related toxicity as pruritus (39.6% vs. 63.6%) and pain of skin (14.6% vs. 25.0%) was less common in group A. Hence, anorexia (41.7% vs 20.5%), nausea (25.0% vs 4.5%), and dysgeusia (22.9% vs 15.9%) occurred more frequently.
Conclusions
Although the frequency of acneiform rash tended to decrease, prophylactic administration of minocycline is not recommended because of increasing gastrointestinal toxicity.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
T. Kozuki: Honoraria (self), Research grant / Funding (self): AstraZeneca; Honoraria (self), Research grant / Funding (self): Chugai Pharmaceutical Co.; Honoraria (self), Research grant / Funding (self): Eli-Lilly Japan; Honoraria (self): Taiho Pharmaceutical Co.; Honoraria (self): Ono Pharmaceutical Co.; Honoraria (self): Bristol-Myers Squibb; Honoraria (self), Research grant / Funding (self): MSD; Honoraria (self): Boehringer Ingelheim; Honoraria (self): Kyowa-Hakko Kirin; Honoraria (self): Pfizer; Honoraria (self): Nippon-kayaku; Research grant / Funding (self): Merck Biopharma. M. Takenoyama: Honoraria (self), Research grant / Funding (self): Chugai Pharmaceutical. All other authors have declared no conflicts of interest.
Resources from the same session
97P - The role of adjuvant chemotherapy according to the status of surgical margin in rectal cancer
Presenter: Jong Hoon Lee
Session: Poster display session
Resources:
Abstract
98P - Influence of DPYD*9, DPYD*6 and GSTP1 ile105val genetic polymorphisms on capecitabine and oxaliplatin (CAPOX) associated toxicities in colorectal cancer patients
Presenter: Ashok Varma
Session: Poster display session
Resources:
Abstract
99P - Patient-derived tumour model by new culture method leading to the precision medicine
Presenter: Norikatsu Miyoshi
Session: Poster display session
Resources:
Abstract
100P - Clinical impact and carcinogenic mechanism of NCAPG overexpression in colon cancer
Presenter: Kai-Yuan Lin
Session: Poster display session
Resources:
Abstract
101P - Combined cellular immunotherapy and chemotherapy improves clinical outcome and displays safety in the treatment of patients with colorectal cancer
Presenter: Chang Wang
Session: Poster display session
Resources:
Abstract
102P - Clinical features of anorectal cancer in patients with Crohn’s disease: Japanese single center study
Presenter: Kazuhiro Watanabe
Session: Poster display session
Resources:
Abstract
103P - Contrast-enhanced CT-based textural parameters as potential prognostic factors of survival for colorectal cancer patients receiving targeted therapy
Presenter: Yanfei Yang
Session: Poster display session
Resources:
Abstract
104P - Prognostic significance of tumour location to the oncologic outcome of colon cancer
Presenter: Sare Hosseini
Session: Poster display session
Resources:
Abstract
105P - Detection and clinical significance of circulating tumour cells in patients with rectal cancer
Presenter: Shuohui Dong
Session: Poster display session
Resources:
Abstract
106P - The risk of malignization incidence in patients with polyps and polyposis of the colon and rectum
Presenter: Yakov Ten
Session: Poster display session
Resources:
Abstract