Skin Toxicity Evaluation Protocol With Panitumumab (STEPP), a Phase II, Open-Label, Randomized Trial Evaluating the Impact of a Pre-Emptive Skin Treatment Regimen on Skin Toxicities and Quality of Life in Patients With Metastatic Colorectal Cancer

Lacouture, Mario E.; Mitchell, Edith P.; Piperdi, Bilal; Pillai, Madhavan V.; Shearer, Heather M.; Iannotti, Nicholas; Xu, Feng; Yassine, Mohamed

doi:10.1200/jco.2008.21.7828

Cited by 403 publications

(367 citation statements)

References 27 publications

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“…Additionally, including various kinds of EGF-R inhibitors (erlotinib, cetuximab, panitumumab, gefitinib), several studies have examined the preventive effects of doxycycline (100mg) or minocycline (100mg) for 6-8 weeks, as well as topical hydrocortisone [20][21][22][23], some of which failed to show a statistically significant effect of tetracycline (500 mg twice a day for 4 weeks), as compared with placebo [20,21]. In a STEPP trial including patients receiving panitumumab with grade 2-3, doxycycline (100 mg twice a day) reduced the incidence of grade 2 to 3 toxicity as compared with placebo (29% versus 62%) at the endopoint of 6 weeks [23]. Another study for patients receiving cetuximab showed that minocycline (100 mg/day) resulted in a favorable response at 4 weeks, rather than at 8 weeks.…”

Section: Folliculitis (Acneiform Eruption)mentioning

confidence: 99%

Erlotinib-induced Adverse Skin Reactions

Yamamoto¹

2013

TOALLJ

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Abstract:Erlotinib is low molecular-weight quinazolin derivatives which selectively inhibit the epidermal growth factor receptor (EGF-R) tyrosine kinase activity of the intracellular domain, block autophosphorylation and the subsequent signaling cascades. EGF-R is expressed on basal keratinocytes, sebocytes, the outer root sheath of hairs, and endothelial cells in the skin, and plays important roles in the regulation of differentiation, proliferation, apoptosis, attachment and migration of keratinocytes, inflammation, and wound healing. Therefore, inhibition of EGF-R causes a number of cutaneous adverse reactions. Among them, severe skin lesions are very stressful, and impair quality of life of patients. Moreover, they even bring disadvantages such as drug withdrawal or interruption. Several review papers describe representative or common skin lesions which appear either during the first a few weeks or at later phases. Common skin manifestations include papular and pustular follicular eruptions (acneiform eruption), xerosis, paronychia, pruritus, and abnormalities of hairs; however, other than those eruptions, several unusual lesions are also induced. Early intervention of dermatologists and management of skin lesions are quite important, because discontinuance of the drug is unfavorable for patients with clinical benefits for cancers. In this brief review, various cutaneous manifestations seen in Japanese patients treated with erlotinib (Tarceva) are shown, and current management of representative severe conditions is also described.

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Section: Folliculitis (Acneiform Eruption)mentioning

confidence: 99%

Erlotinib-induced Adverse Skin Reactions

Yamamoto¹

2013

TOALLJ

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“…Our study was aimed at assessing the efficacy of tetracyclines in general, and the various treatments used were considered equivalent. The incidence of grade 2-3 folliculitis was used for the meta-analysis, but the date or time interval specified varied depending on the study: in the fourth week for two studies [71,73], during the first 6 weeks for one study [70], and during the first 4 months for one study [72]. Regarding the natural course of folliculitis induced by EGFRIs, heterogeneity in terms of the time for quantification of folliculitis did not constitute a bias when analyzing the results.…”

Section: Discussionmentioning

confidence: 99%

“…In preventive therapy, only the STEPP study was positive in terms of its primary endpoint [70]. In that study, the treatment arm comprised doxycycline at a dose of 100 mg twice a day for a period of 6 weeks.…”

Section: Discussionmentioning

confidence: 99%

“…In that study, the treatment arm comprised doxycycline at a dose of 100 mg twice a day for a period of 6 weeks. This dosage and duration of treatment should be recommended for preventive therapy, but a daily dose of 100 mg could be sufficient [70,72]. Regarding the duration of treatment, 4 weeks of preventive therapy seems inadequate.…”

Section: Discussionmentioning

confidence: 99%

“…The NCI-CTCAE, version 3.0, classification was used in the four studies [70 -73]. Only the Skin Toxicity Evaluation Protocol Panitumumab [STEPP] study was positive in terms of its primary objective, which was to lead to a lower incidence of grade 2-3 folliculitis during the first 6 weeks of treatment: 29.2% (n ϭ 14 or 48) versus 61.7% (n ϭ 29 of 47) (odds ratio [OR], 0.256; 95% confidence interval [CI], 0.099 -0.652; p ϭ .0014) [70]. In the other three studies, the primary objective was not reached but a lower incidence of grade 2-3 folliculitis was observed in the tetracycline arm in all cases [71][72][73].…”

Section: Preventive Tetracyclinesmentioning

confidence: 99%

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Folliculitis Induced by EGFR Inhibitors, Preventive and Curative Efficacy of Tetracyclines in the Management and Incidence Rates According to the Type of EGFR Inhibitor Administered: A Systematic Literature Review

et al. 2012

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Introduction. Folliculitis is the most common side effect of epidermal growth factor receptor (EGFR) inhibitors (EGFRIs). It is often apparent, altering patients' quality of life and possibly impacting compliance. Variations in terms of the treatment‐related incidence and intensity have not been fully elucidated. Tetracyclines have been recommended for the prophylaxis and treatment of folliculitis but their efficacy is yet to be established. Materials and Methods. We carried out two systematic literature reviews. The first assessed the preventive and curative efficacy of tetracyclines. The second assessed the incidence of grade 3–4 folliculitis in the main clinical studies published. Results. In four randomized studies, preventive tetracycline treatment was associated with a significantly lower incidence of grade 2–3 folliculitis and a better quality of life in three of the four studies. In curative terms, tetracycline efficacy was not evaluated in any randomized study, but an improvement in grade ≥2 folliculitis was reported in case series. The frequency and severity of folliculitis seem to be greater with the antibodies than with the tyrosine kinase inhibitors. Analysis restricted to lung cancer studies showed a statistically greater incidence in terms of grade 3–4 folliculitis with cetuximab (9%) and erlotinib (8%) than with gefitinib (2%) (p < .0001). Conclusion. Unless contraindicated, a tetracycline should be routinely prescribed prophylactically for patients treated with an EGFRI (level of evidence, B2). In curative therapy, the level of evidence for tetracycline efficacy is low (level of evidence, D). The incidence of grade 3–4 folliculitis induced by EGFRIs appears to be lower with gefitinib.

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Economic Burden of Dermatologic Adverse Events Induced by Molecularly Targeted Cancer Agents

Borovicka¹

2011

Arch Dermatol

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Skin Toxicity Evaluation Protocol With Panitumumab (STEPP), a Phase II, Open-Label, Randomized Trial Evaluating the Impact of a Pre-Emptive Skin Treatment Regimen on Skin Toxicities and Quality of Life in Patients With Metastatic Colorectal Cancer

Cited by 403 publications

References 27 publications

Erlotinib-induced Adverse Skin Reactions

Erlotinib-induced Adverse Skin Reactions

Folliculitis Induced by EGFR Inhibitors, Preventive and Curative Efficacy of Tetracyclines in the Management and Incidence Rates According to the Type of EGFR Inhibitor Administered: A Systematic Literature Review

Economic Burden of Dermatologic Adverse Events Induced by Molecularly Targeted Cancer Agents

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