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

Kripp, Melanie; Prasnikar, Nicole; Vehling-Kaiser, Ursula; Quidde, Julia; Al‐Batran, Salah‐Eddin; Stein, Alexander; Neben, Kai; Hannig, Carla; Tessen, H.W.; Trarbach, Tanja; Hinke, Axel; Hofheinz, Ralf–Dieter

doi:10.18632/oncotarget.21249

Cited by 12 publications

(11 citation statements)

References 19 publications

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“…Underreporting of known and thus expected adverse drug reactions is a known bias in observational research. Additionally, evidence from clinical studies [27] as well as the availability of respective guidelines suggests that physicians’ experience with managing EGFR inhibitor-related skin reactions is increasing. It can be assumed that patients are now treated more proactively with skin ointments, sun protection, skin moisturizers, and other measures to prevent skin reactions, compared with the earlier years of use of panitumumab in daily clinical routine.…”

Section: Discussionmentioning

confidence: 99%

Prospective Observational Cohort Study to Describe the Use of Panitumumab in Combination with Chemotherapy in Real-World Clinical Practice for Patients with Wild-Type RAS mCRC

Hebart¹,

Kiehl

Tomášek

et al. 2019

Adv Ther

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IntroductionThis study aimed to better understand panitumumab use in real-life clinical practice in first- and second-line treatment of metastatic colorectal cancer in five European countries.MethodsThis is a combined analysis of two observational, non-interventional prospective cohort studies, one of which was conducted in Germany and France, the other in Bulgaria, Czech Republic, and Hungary. The studies observed patients with wild-type [Kirsten] rat sarcoma viral oncogene homolog ([K]RAS/RAS) metastatic colorectal cancer (mCRC), who had been treated with panitumumab in combination with fluorouracil, leucovorin, and oxaliplatin (FOLFOX) in the first line or with panitumumab combined with fluorouracil, leucovorin, and irinotecan (FOLFIRI) in the second line following fluoropyrimidine-based chemotherapy. The planned duration of observation was 12 months from the first dose of panitumumab.ResultsA total of 332 patients treated with panitumumab + FOLFOX in the first line and 94 patients treated with panitumumab + FOLFIRI in the second line were analyzed. The median number of panitumumab infusions was 10.0 in first-line FOLFOX patients and 11.5 in second-line FOLFIRI patients; the median duration of panitumumab exposure was 5.7 and 6.9 months, respectively. The unadjusted overall response rate (complete or partial response) in patients with available post-baseline response assessment (n = 290) was 51.7% in first-line FOLFOX and 44.9% in second-line FOLFIRI patients. In the first-line setting, resectability was achieved in 9.3%. Reported hospitalizations were mostly cancer-related visits such as scheduled anticancer treatment administrations, tumor assessment visits, or interventions. The majority of adverse drug reactions were skin disorders, with 75.3% in first-line FOLFOX patients and 72.3% in second-line FOLFIRI patients.ConclusionOverall, the study results show that treatment patterns, clinical efficacy, and the safety profile of panitumumab in routine clinical practice were comparable to those in randomized controlled trials. The relatively low skin toxicity rate could be attributed to increasing experience in managing panitumumab-associated rash and some degree of underreporting.FundingAmgen.Electronic supplementary materialThe online version of this article (10.1007/s12325-019-0874-6) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

Prospective Observational Cohort Study to Describe the Use of Panitumumab in Combination with Chemotherapy in Real-World Clinical Practice for Patients with Wild-Type RAS mCRC

Hebart¹,

Kiehl

Tomášek

et al. 2019

Adv Ther

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“…In fact, in the present study, all patients were treated not only with skin moisturizers, sunscreen, and topical steroids but also with doxycycline at 100 mg once daily. Oral tetracycline represents a well-established preventive treatment [21, 22]. …”

Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Cetuximab plus Radiotherapy in Cisplatin-Unfit Elderly Patients with Advanced Squamous Cell Head and Neck Carcinoma: A Retrospective Study

et al. 2019

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Introduction: Concurrent platinum-based chemoradiation currently represents the standard treatment for advanced head and neck cancer (HNC), but it induces a significant toxicity, in particular among elderly patients. Elderly and unfit patients have been underrepresented in clinical trials and there is a need for tailored guidelines. Methods: A retrospective review of clinical data of HNC patients treated at the Operative Oncology Unit of the San Giovanni di Dio Hospital in Frattamaggiore (Naples, Italy) was performed. At study entry, a comprehensive assessment including absolute contraindications for cisplatin use, as well as comorbidities, socioeconomic status, BMI, and weight loss, was performed. The treatment included high-dose radiotherapy plus weekly cetuximab (initially at a dose of 400 mg/m²of body surface area and thereafter at 250 mg weekly during the whole radiotherapy). The aim of this study was to evaluate the activity and toxicity of this schedule in a series of patients aged older than 69 years. Results: Between May 30, 2013, and March 30, 2015, sixty-four patients (age range, 69–87 years; median age, 73.7 years; male/female ratio, 46/18) were treated. The overall response rate was 67% in this series of patients. The disease control rate was 76%. Disease progression was recorded in 25% of the patients. The median duration of loco-regional control was 17 months (range, 15.8–17.7 months). PFS was 14.8 months (range, 13.9–15.5 months). The overall survival was 34 months, with a median follow-up of 41.0 months (range, 31.1–36.8 months). The main grade 3/4 adverse events were acne rash in 52% and radiation dermatitis in 32% of the cases. Conclusion: Cetuximab plus radiotherapy appears to be feasible and active in elderly patients unsuitable for cisplatin treatment. The treatment was supported by a favorable toxicity profile.

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“…After full-text review, a total of 26 articles were included in the qualitative synthesis and 15 in the quantitative synthesis. [14][15][16][18][19][20][23][24][25][26][27][28]30,31,36…”

Section: Search Strategymentioning

confidence: 99%

Prevention and management of acneiform rash associated with EGFR inhibitor therapy: A systematic review and meta‐analysis

Gorji

Joseph

Pavlakis

et al. 2022

Asia-Pac J Clncl Oncology

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Introduction Epidermal growth factor receptor (EGFR) inhibitors are established therapies for advanced lung, colorectal, and head and neck cancers. They commonly cause acneiform eruptions that affect patient quality of life and may lead to discontinuation of therapy. Methods A systematic review and meta‐analysis was undertaken to assess strategies for the prevention and reactive management of acneiform rash associated with EGFR inhibitor therapy for advanced lung, colorectal, and head and neck cancers. A systematic Medline, Embase, and EBM Reviews database search was conducted on the 2nd of January 2021. The Preferred Reporting Items for Systematic Reviews and Meta‐analyses statement was followed and the studies were critically appraised. Studies were selected if they focused on preventing or treating acneiform eruptions in adults being treated for advanced lung cancer, colorectal cancer, and head and neck cancers with EGFR inhibitors. Results Oral antibiotics had the greatest efficacy in preventing grade 2 or higher acneiform eruptions with a relative risk reduction of 40% (RR = .6, 95% CI .46–.79, p < .01). Other treatment modalities did not have statistically significant results. Topical antibiotics had a total relative risk reduction of 19% (RR = .81, 95% CI .45–1.48, p = .5). Vitamin K1 cream did not reduce the relative risk (RR = 1.08, 95% CI .45–1.48, p = .50). Sunscreen had a total relative risk reduction of 25% (RR = .75, 95% CI .49–1.14, p = .18). Conclusions The results of this meta‐analysis reinforce the fact that oral tetracycline antibiotics are the most efficacious prophylactic option for acneiform eruptions in EGFR inhibitors. They should be offered to suitable patients commencing treatment and used with a general skin‐care routine involving emollients and avoidance of irritants.

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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

Cited by 12 publications

References 19 publications

Prospective Observational Cohort Study to Describe the Use of Panitumumab in Combination with Chemotherapy in Real-World Clinical Practice for Patients with Wild-Type RAS mCRC

Prospective Observational Cohort Study to Describe the Use of Panitumumab in Combination with Chemotherapy in Real-World Clinical Practice for Patients with Wild-Type RAS mCRC

Efficacy and Safety of Cetuximab plus Radiotherapy in Cisplatin-Unfit Elderly Patients with Advanced Squamous Cell Head and Neck Carcinoma: A Retrospective Study

Prevention and management of acneiform rash associated with EGFR inhibitor therapy: A systematic review and meta‐analysis

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