Dermatux: phase IV trial of Cetuximab plus FOLFIRI in first-line metastatic colorectal cancer receiving a pre-defined skin care

Schimanski, Carl Christoph; Staib, Frank; Göhler, Thomas; Hebart, Holger; Heike, Michael; Neise, Michael; Rudi, Jochen; Geer, Thomas; Dingeldein, Gerrit; Lang, Claudia; Ehscheidt, Peter; Flohr, Thomas; Josten, K.; Karthaus, Meinolf; Schmittel, Alexander; Wierecky, Jan; Boller, Emil; Indorf, Martin; Wörns, Marcus‐Alexander; Galle, Peter R.; Moehler, Markus

doi:10.1007/s00432-017-2344-3

Cited by 6 publications

(4 citation statements)

References 20 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…in one patient at each dose level. According to previous studies, such skin reactions caused by cetuximab are well manageable (10,11,24). In addition, a grade ≥2 acneiform rash was reported to be a marker for response to treatment with cetuximab (25).…”

Section: Definition Of Dose Limiting Toxicities (Dlts)mentioning

confidence: 99%

Phase I Study of Definitive Radio-chemotherapy with Cisplatin, 5-Fluorouracil and Cetuximab for Unresectable Locally Advanced Esophageal Cancer

Rades

Maderer

Panzner

et al. 2017

View full text Add to dashboard Cite

show abstract

Section: Definition Of Dose Limiting Toxicities (Dlts)mentioning

confidence: 99%

Phase I Study of Definitive Radio-chemotherapy with Cisplatin, 5-Fluorouracil and Cetuximab for Unresectable Locally Advanced Esophageal Cancer

Rades

Maderer

Panzner

et al. 2017

View full text Add to dashboard Cite

show abstract

“…Accurate grading of the papulopustular eruption is necessary in order to determine the severity of the skin toxicity and to establish the correct dermatological treatment. Furthermore, the standardized questionnaire used in oncology trials, Common Terminology Criteria for Adverse Events (CTCAE) [21,22], is the most commonly used in medical practice. In this study, we used CTCAE, the most recent version 5.0, which allowed the assessment of papulopustular rash as grades 1-5.…”

Section: Discussionmentioning

confidence: 99%

A Preliminary Study Examining the Correlation between EGFRI Treatment, Clinic Dermatoscopy Features, and Serum Levels of Anti-Alpha-Galactosyl IgE in Colorectal Cancer Patients

Popa,

Cherciu Harbiyeli,

Ciurea

et al. 2024

Gastroenterology Insights

View full text Add to dashboard Cite

The introduction of molecularly targeted therapies, particularly the epidermal growth factor receptor inhibitors (EGFRIs), has had a positive impact by increasing the life expectancy of patients with advanced colorectal cancer (CRC). The most used anti-EGFRIs monoclonal antagonist, Cetuximab, induces skin responses in most patients, leading to a reduction of dosages or even therapy discontinuation, all with devastating effects. Our study aimed to assess the predictive role and the possible correlations of clinical features, imaging aspects (dermatoscopy), and laboratory tests (anti-alpha-galactosyl IgE levels) for early detection of Cetuximab skin toxicity in patients with metastatic CRC. The association of IgE antibodies against goat alpha-1,3-galactose serum levels with various degrees of skin toxicity encountered during the oncologic treatment resulted in higher concentrations in patients with pruritus and hair changes. Incorporating dermatoscopy into the routine dermatological consultation allowed us to perform a severity assessment, dynamically record, and identify even the erupting lesions previously invisible to classical examination. Hence, we were enabled to generate a broad report and to classify various degrees of skin toxicity severity linked to Cetuximab treatment in 19 patients with metastatic CRC. Detecting the emergent lesions and initiating dermatological treatment in the early stages decreased the severity of skin toxicity. As a result, the duration of the antibiotic treatment was much shorter, and the risk of dose reduction or interruption of the cancer treatment was diminished. In conclusion, we emphasize the need for a regular dermatological examination with dermatoscopy of CRC patients undergoing Cetuximab treatment. Skin toxicity is a significant concern for these patients, and healthcare providers should be vigilant in monitoring and managing this side effect in order to optimize patient care. The correlation between anti-alpha-Gal IgE levels and Cetuximab-induced skin toxicities is an emerging area. More extensive studies need to be published in order to establish this relationship directly.

show abstract

“…High expectations are placed on vitamin K for use of EGFR treatment associated skin toxicity. The prophylactic use of K1 cream was demonstrated by Ocvirk [ 16 ] and – most recently – by Schimanski et al [ 17 ]. Regarding this, the results of the EVITA trial (NCI01345526) are eagerly awaited.…”

Section: Discussionmentioning

confidence: 99%

AIO LQ-0110: a randomized phase II trial comparing oral doxycycline versus local administration of erythromycin as preemptive treatment strategies of panitumumab-mediated skin toxicity in patients with metastatic colorectal cancer

et al. 2017

View full text Add to dashboard Cite

BackgroundDermatologic toxicities, especially akne-like skin rash, are the most common side-effects associated with anti-epidermal growth factor receptor (EGFR) therapy. Preemptive treatment with oral tetracyclines is recommended as a standard. Topical prophylactic options have thus far not been compared to tetracyclines. In the current study, we sought to establish an alternative topical treatment.Patients and methodsIn this multicentre, randomized, open-label phase II study patients with (K)Ras-wildtype colorectal cancer receiving panitumumab were randomized (1:1) to receive either doxycycline 100 mg b.i.d. (standard arm) or erythromycin ointment 2% followed by doxycycline in case of insufficient activity. The primary endpoint was the percentage of patients developing no skin toxicity ≥ grade 2 at any time during the first 8 weeks of panitumumab treatment. Skin toxicity was assessed using the NCI CTCAE v 4.0. Secondary endpoints comprised the assessment of skin toxicity using a more thorough grading system (WoMo score), evaluation of skin-related (DLQI) and global quality of life (EORTC QLQ C30).ResultsIn total, 88 patients were included in this trial. 69% of the patients in the erythromycin arm suffered from skin toxicity of grade ≥ 2 versus 63% in the standard arm (P = n.s.). However, as per WoMo score significantly more patients in the erythromycin arm developed moderate or severe skin toxicity at earlier time points. Skin related and overall quality of life was comparable between both arms.ConclusionsBased on this data erythromycin cannot be regarded as an alternative to doxycycline as prevention of EGFR-related skin toxicity.

show abstract

Dermatux: phase IV trial of Cetuximab plus FOLFIRI in first-line metastatic colorectal cancer receiving a pre-defined skin care

Abstract: Our data reveal encouraging improvements in skin reactions and their time to occurrence due to a pre-defined skin care.

Cited by 6 publications

References 20 publications

Phase I Study of Definitive Radio-chemotherapy with Cisplatin, 5-Fluorouracil and Cetuximab for Unresectable Locally Advanced Esophageal Cancer

Phase I Study of Definitive Radio-chemotherapy with Cisplatin, 5-Fluorouracil and Cetuximab for Unresectable Locally Advanced Esophageal Cancer

A Preliminary Study Examining the Correlation between EGFRI Treatment, Clinic Dermatoscopy Features, and Serum Levels of Anti-Alpha-Galactosyl IgE in Colorectal Cancer Patients

AIO LQ-0110: a randomized phase II trial comparing oral doxycycline versus local administration of erythromycin as preemptive treatment strategies of panitumumab-mediated skin toxicity in patients with metastatic colorectal cancer

Contact Info

Product

Resources

About