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
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Melanie Kripp1,*, Nicole Prasnikar2,*, Ursula Vehling-Kaiser3, Julia Quidde4, Salah-Eddin Al-Batran5, Alexander Stein4, Kai Neben6, Carla Verena Hannig7, Hans Werner Tessen8, Tanja Trarbach9, Axel Hinke10 and Ralf-Dieter Hofheinz11
1Medizinische Klinik 3, Hämatologie und Onkologie, Universitätsmedizin Mannheim, Mannheim, Germany
2Hämatologie, Internistische Onkologie und Palliativmedizin, Asklepios Klinik Barmbek, Hamburg, Germany
3Tagesklinik für Hämatologie, Onkologie, Palliativmedizin, Landshut, Germany
4Universitäres Cancer Center, UKE Hamburg, Hamburg, Germany
5Universitäres Centrum für Tumorerkrankungen, Krankenhaus Nordwest, Frankfurt, Germany
6Medizinische Klinik II, Klinikum Mittelbaden, Baden-Baden, Germany
7Onkologisches Gemeinschaftspraxis, Bottrop/Dorsten, Germany
8Onkologische Kooperation Harz, Goslar, Germany
9Zentrum für Tumorbiologie und Integrative Medizin, Klinikum Wilhelmshaven, Wilhelmshaven, Germany
10WiSP Wissenschaftlicher Service Pharma GmbH, Langenfeld, Germany
11Interdisziplinäres Tumorzentrum, Universitätsmedizin Mannheim, Universität Heidelberg, Heidelberg, Germany
*These authors have contributed equally to this work
Melanie Kripp, email: [email protected]
Keywords: doxycycline, erythromycin, panitumumab, skin toxicity, WoMo score
Received: July 12, 2017 Accepted: August 08, 2017 Published: September 23, 2017
Background: Dermatologic 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 methods: In 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).
Results: In 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.
Conclusions: Based on this data erythromycin cannot be regarded as an alternative to doxycycline as prevention of EGFR-related skin toxicity.
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