- Email: [email protected]
Management of common vismodegib (VISMO)-related adverse events in patients with locally advanced basal cell carcinoma (laBCC): RegiSONIC Disease Registry Study
3775
3514
Interest of dermatologic supportive care with specific hydrotherapy after breast cancer treatment: A randomized multicenter controlled clinical study Florence Dalenc, MD, Institut Claudius Regaud, Toulouse, France; Dider Guerrero, MD, Laboratoires Avene PFDC, Lavaur, France; Virginie Ribet, PharmD, PFDC, Toulouse, France; Victor Georgescu, MD, Laboratoires Avene PFDC, Lavaur, France; Juliette Guyonnaud, PharmD, PFDC, Toulouse, France; Marina Gurdak, PharmD, PFDC, Toulouse, France; Vincent Sibaud, MD, Institut Claudius Regaud, Toulouse, France; Ana Beatris Rossi, MD, PFDC, Toulouse, France
Management of common vismodegib (VISMO)-related adverse events in patients with locally advanced basal cell carcinoma (laBCC): RegiSONIC Disease Registry Study Mario E. Lacouture, MD, Memorial Sloan-Kettering Cancer Center, New York, NY, United States; Julie Guillen, RN, MSN, University of California, San Francisco, San Francisco, CA, United States; Ragini Kudchadkar, MD, Emory University, Atlanta, GA, United States; Gary Rogers, MD, Tufts University School of Medicine, Beverly, MA, United States; Thomas Olencki, DO, Ohio State University Medical Center, Columbus, OH, United States; Jean Tang, MD, PhD, Stanford University School of Medicine, Redwood City, CA, United States; Simon Yoo, MD, Northwestern University, Chicago, IL, United States; Keith Dawson, MS, Genentech, Inc, South San Francisco, CA, United States; Yong Mun, PhD, Genentech, Inc, South San Francisco, CA, United States; Aleksandar Sekulic, MD, PhD, Mayo Clinic Scottsdale, Scottsdale, AZ, United States
Introduction: Treatment of breast cancer in an adjuvant setting is associated with significant dermatologic adverse events. The skin toxicities induced by chemotherapy, surgery or radiotherapy negatively impact patients’ quality of life (QoL), not only during but also several months after cancer treatment. This controlled study assessed the interest of a specific hydrotherapy performed just after cancer management on QoL and dermatologic adverse events. Materials and methods: 68 women (mean 52 yo) in complete remission after a standardized (neo-) adjuvant treatment (chemotherapy, radiotherapy, surgery) for infiltrating breast carcinoma RH+ HER2- were included by oncologists. Specific hydrotherapy management was performed in Avene-Les-Bains center (France) and mainly included daily thermal water showers and massages, with optimized skin care therapy during 3 weeks (HG, n ¼ 35). In the control group (CG, n ¼ 33), best dermatologic supportive cares were allowed. Patients were randomized after the end of radiotherapy (1 to 5 weeks) (inclusion visit) with at least 2 skin toxicities $ grade 1 (dry skin, hyperpigmentation, skin induration, pain of skin, pruritus, lymphedema, hand-foot syndrome, radiodermatitis, nail toxicity, other). Primary endpoint was the assessment of the European Organization for Research and Treatment of Cancer QoL Questionnaire Breast Cancer (EORTC QLQ-BR23) from D0 (hydrotherapy start) to D18 (hydrotherapy end). Secondary endpoints included measurements of dermatologic side effects due to anticancer treatments (assessed using National Cancer Institute-Common Terminology Criteria for Adverse Events, NCI CTCAE v4), dermatologic QoL (DLQI), health global status (EORTC QLQ-C30), psychological well-being and self-perceived general health (PGWBI) questionnaires. Results: At D18, intergroup comparison demonstrated a significant difference in favor of HG for 9 different items: lymphedema (P ¼ .0015), symptoms linked to cancer (P ¼.0001), side effects due to treatment (P \.005) and physical image (P ¼ .0139) (EORTC QLQ-BR23); dry skin (P \.0001), nail loss (P ¼.001), pruritus (P ¼ .0113), skin hyperpigmentation (P \ .05) and skin induration (P \ .005) (NCI CTCAE). In addition, the DLQI and the PGWBI global scores were significantly improved in HG patients compared to CG patients (P \ .0005 and P \ .005, respectively). The EORTC QLQ-C30 was also improved at the end of hydrotherapy: status of QoL (P \.005), emotional functioning (P ¼ .0001), fatigue (P ¼ .017). Conclusion: QoL is severely impaired in female patients treated for breast cancer. Specific dermatologic supportive care in breast cancer survivors significantly improves patients QoL, well-being and reduces dermatologic symptoms due to anticancer treatments.
Background: RegiSONIC (NCT01604252) is an ongoing prospective, observational cohort study collecting real-world data on treatment patterns and outcomes in patients (pts) with advanced BCC (aBCC) and/or BCC nevus syndrome (BCCNS). We present the incidence and management of common adverse events (AEs) associated with VISMO in pts with laBCC on VISMO (150 mg/d). Methods: Pts enroll in 3 cohorts (C): newly diagnosed aBCC pts (C1), aBCC pts who previously received VISMO in a Genentech-sponsored study (C2), or pts with BCCNS who have aBCC or multiple BCCs of any stage (C3). Pts are being treated according to clinician’s standard of care and clinicians were requested to report AEs, serious AEs, and AEs with fatal outcomes. Results: As of Feb 13, 2015, 362 pts with laBCC were enrolled (344 in C1, 4 in C2, and 14 in C3). 96 (27%) of these pts were treated with VISMO (received VISMO #90 d of determination of laBCC); 64 (67%) were male and median age was 67 y (range, 34-99). 78 of the 96 (81%) pts experienced any protocol-specified AE, and serious AEs occurred in 14 (15%) pts. A total of 231 VISMO-related AEs occurred in 71 (74%) pts, leading to discontinuation in 20% (14/71), temporary interruption in 25% (18/71), and dose reduction in 8% (6/71; VISMO capsule does not enable dose reduction \150 mg/d; reductions included other dosing schedules, including dose holds). 64 muscle spasm AEs occurred in 48% (46/96) of pts; management included drug treatment (28% of AEs; most commonly cyclobenzaprine hydrochloride for 14% of AEs), nondrug treatment (5%), or discontinuation or interruption of VISMO (30%), while 59% had no treatment indicated. Pts may have multiple AEs and multiple treatments for each AE. 62 ageusia/dysgeusia AEs were reported by 53% of pts (51/96); management included drug treatment (3% of AEs; Biotene spray and megestrol acetate in 1 pt each) or discontinuation or interruption (24%), while 77% had no treatment indicated. 38 alopecia AEs were reported by 38% (36/96) of pts; management included drug treatment (11% of AEs; bimatoprost [1 pt], diflorasone diacetate [1 pt], and minoxidil [2 pts]), or discontinuation or interruption (24%), while 82% had no treatment indicated. Conclusions: Muscle spasms, taste disturbances, and alopecia were common in VISMO-treated laBCC pts in the real-world setting, consistent with AEs reported from clinical trials. Common AE management strategies included interruption or discontinuation, and muscle spasms were also often treated with drugs.
Supported by PFDC. Supported by Hoffmann-LaRoche.
2916
3000 Malignant degeneration of chronic ulcer in an long evolution leprosy patient Lucıa Ascanio, Hospital Universitario Fundaci on Alcorc on, Madrid, Spain; Ximena Rodriguez, Hospital Universitario Fundaci on Alcorc on, Madrid, Spain; Floristan Uxua, Hospital Universitario Fundaci on Alcorc on, Madrid, Spain; Jose Luis L opez-Estebaranz, Hospital Universitario Fundaci on Alcorc on, Madrid, Spain Nonhealing trophic ulcers in leprosy are a common phenomenon, but acute malignant transformations them, are relatively rare. A case of squamous cell carcinoma developing in trophic ulcer in leprosy is presented. A 81-year-old man, with a history of chronic ulcers with torpid evolution of both legs secondary to Hansen’s disease thirty years ago, presented to our external clinic with a 3-year history of trophic ulcer of the right foot. He presented with a rapid growing excrescence that was proposed for biopsy. The anatomopathologic features were consistent with squamous cell carcinoma. The nuclear magnetic resonance revealed a mass on the posterior region, of the right ankle infiltrating deep structures (tendons, muscles, bone). Amputation was performed. Squamous cell carcinoma (SCC) arising in chronic ulcers of leprosy patients is uncommon. Most occur in leprosy-endemic countries (India, Africa and Latin America). In Spain, few cases have been described Marjolin ulcers in patients with leprosy. Marjolin ulcer is a welldefined, but uncommon malignant ulcer that occurs in chronic wounds and cutaneous scars. Most of the tumors are relatively slow growing and tend to metastasize late with an average time of approximately 25 years. Various theories concerning pathogenesis of Marjolin ulcer have been proposed. Well-differentiated squamous cell carcinoma is the most common histological type of Marjolin ulcer. Biopsy with histopathologic interpretation remains the gold standard for the diagnosis, with radical surgical excision being the treatment of choice. Commercial support: None identified.
AB200
J AM ACAD DERMATOL
MAY 2016
3514
Interest of dermatologic supportive care with specific hydrotherapy after breast cancer treatment: A randomized multicenter controlled clinical study Florence Dalenc, MD, Institut Claudius Regaud, Toulouse, France; Dider Guerrero, MD, Laboratoires Avene PFDC, Lavaur, France; Virginie Ribet, PharmD, PFDC, Toulouse, France; Victor Georgescu, MD, Laboratoires Avene PFDC, Lavaur, France; Juliette Guyonnaud, PharmD, PFDC, Toulouse, France; Marina Gurdak, PharmD, PFDC, Toulouse, France; Vincent Sibaud, MD, Institut Claudius Regaud, Toulouse, France; Ana Beatris Rossi, MD, PFDC, Toulouse, France
Management of common vismodegib (VISMO)-related adverse events in patients with locally advanced basal cell carcinoma (laBCC): RegiSONIC Disease Registry Study Mario E. Lacouture, MD, Memorial Sloan-Kettering Cancer Center, New York, NY, United States; Julie Guillen, RN, MSN, University of California, San Francisco, San Francisco, CA, United States; Ragini Kudchadkar, MD, Emory University, Atlanta, GA, United States; Gary Rogers, MD, Tufts University School of Medicine, Beverly, MA, United States; Thomas Olencki, DO, Ohio State University Medical Center, Columbus, OH, United States; Jean Tang, MD, PhD, Stanford University School of Medicine, Redwood City, CA, United States; Simon Yoo, MD, Northwestern University, Chicago, IL, United States; Keith Dawson, MS, Genentech, Inc, South San Francisco, CA, United States; Yong Mun, PhD, Genentech, Inc, South San Francisco, CA, United States; Aleksandar Sekulic, MD, PhD, Mayo Clinic Scottsdale, Scottsdale, AZ, United States
Introduction: Treatment of breast cancer in an adjuvant setting is associated with significant dermatologic adverse events. The skin toxicities induced by chemotherapy, surgery or radiotherapy negatively impact patients’ quality of life (QoL), not only during but also several months after cancer treatment. This controlled study assessed the interest of a specific hydrotherapy performed just after cancer management on QoL and dermatologic adverse events. Materials and methods: 68 women (mean 52 yo) in complete remission after a standardized (neo-) adjuvant treatment (chemotherapy, radiotherapy, surgery) for infiltrating breast carcinoma RH+ HER2- were included by oncologists. Specific hydrotherapy management was performed in Avene-Les-Bains center (France) and mainly included daily thermal water showers and massages, with optimized skin care therapy during 3 weeks (HG, n ¼ 35). In the control group (CG, n ¼ 33), best dermatologic supportive cares were allowed. Patients were randomized after the end of radiotherapy (1 to 5 weeks) (inclusion visit) with at least 2 skin toxicities $ grade 1 (dry skin, hyperpigmentation, skin induration, pain of skin, pruritus, lymphedema, hand-foot syndrome, radiodermatitis, nail toxicity, other). Primary endpoint was the assessment of the European Organization for Research and Treatment of Cancer QoL Questionnaire Breast Cancer (EORTC QLQ-BR23) from D0 (hydrotherapy start) to D18 (hydrotherapy end). Secondary endpoints included measurements of dermatologic side effects due to anticancer treatments (assessed using National Cancer Institute-Common Terminology Criteria for Adverse Events, NCI CTCAE v4), dermatologic QoL (DLQI), health global status (EORTC QLQ-C30), psychological well-being and self-perceived general health (PGWBI) questionnaires. Results: At D18, intergroup comparison demonstrated a significant difference in favor of HG for 9 different items: lymphedema (P ¼ .0015), symptoms linked to cancer (P ¼.0001), side effects due to treatment (P \.005) and physical image (P ¼ .0139) (EORTC QLQ-BR23); dry skin (P \.0001), nail loss (P ¼.001), pruritus (P ¼ .0113), skin hyperpigmentation (P \ .05) and skin induration (P \ .005) (NCI CTCAE). In addition, the DLQI and the PGWBI global scores were significantly improved in HG patients compared to CG patients (P \ .0005 and P \ .005, respectively). The EORTC QLQ-C30 was also improved at the end of hydrotherapy: status of QoL (P \.005), emotional functioning (P ¼ .0001), fatigue (P ¼ .017). Conclusion: QoL is severely impaired in female patients treated for breast cancer. Specific dermatologic supportive care in breast cancer survivors significantly improves patients QoL, well-being and reduces dermatologic symptoms due to anticancer treatments.
Background: RegiSONIC (NCT01604252) is an ongoing prospective, observational cohort study collecting real-world data on treatment patterns and outcomes in patients (pts) with advanced BCC (aBCC) and/or BCC nevus syndrome (BCCNS). We present the incidence and management of common adverse events (AEs) associated with VISMO in pts with laBCC on VISMO (150 mg/d). Methods: Pts enroll in 3 cohorts (C): newly diagnosed aBCC pts (C1), aBCC pts who previously received VISMO in a Genentech-sponsored study (C2), or pts with BCCNS who have aBCC or multiple BCCs of any stage (C3). Pts are being treated according to clinician’s standard of care and clinicians were requested to report AEs, serious AEs, and AEs with fatal outcomes. Results: As of Feb 13, 2015, 362 pts with laBCC were enrolled (344 in C1, 4 in C2, and 14 in C3). 96 (27%) of these pts were treated with VISMO (received VISMO #90 d of determination of laBCC); 64 (67%) were male and median age was 67 y (range, 34-99). 78 of the 96 (81%) pts experienced any protocol-specified AE, and serious AEs occurred in 14 (15%) pts. A total of 231 VISMO-related AEs occurred in 71 (74%) pts, leading to discontinuation in 20% (14/71), temporary interruption in 25% (18/71), and dose reduction in 8% (6/71; VISMO capsule does not enable dose reduction \150 mg/d; reductions included other dosing schedules, including dose holds). 64 muscle spasm AEs occurred in 48% (46/96) of pts; management included drug treatment (28% of AEs; most commonly cyclobenzaprine hydrochloride for 14% of AEs), nondrug treatment (5%), or discontinuation or interruption of VISMO (30%), while 59% had no treatment indicated. Pts may have multiple AEs and multiple treatments for each AE. 62 ageusia/dysgeusia AEs were reported by 53% of pts (51/96); management included drug treatment (3% of AEs; Biotene spray and megestrol acetate in 1 pt each) or discontinuation or interruption (24%), while 77% had no treatment indicated. 38 alopecia AEs were reported by 38% (36/96) of pts; management included drug treatment (11% of AEs; bimatoprost [1 pt], diflorasone diacetate [1 pt], and minoxidil [2 pts]), or discontinuation or interruption (24%), while 82% had no treatment indicated. Conclusions: Muscle spasms, taste disturbances, and alopecia were common in VISMO-treated laBCC pts in the real-world setting, consistent with AEs reported from clinical trials. Common AE management strategies included interruption or discontinuation, and muscle spasms were also often treated with drugs.
Supported by PFDC. Supported by Hoffmann-LaRoche.
2916
3000 Malignant degeneration of chronic ulcer in an long evolution leprosy patient Lucıa Ascanio, Hospital Universitario Fundaci on Alcorc on, Madrid, Spain; Ximena Rodriguez, Hospital Universitario Fundaci on Alcorc on, Madrid, Spain; Floristan Uxua, Hospital Universitario Fundaci on Alcorc on, Madrid, Spain; Jose Luis L opez-Estebaranz, Hospital Universitario Fundaci on Alcorc on, Madrid, Spain Nonhealing trophic ulcers in leprosy are a common phenomenon, but acute malignant transformations them, are relatively rare. A case of squamous cell carcinoma developing in trophic ulcer in leprosy is presented. A 81-year-old man, with a history of chronic ulcers with torpid evolution of both legs secondary to Hansen’s disease thirty years ago, presented to our external clinic with a 3-year history of trophic ulcer of the right foot. He presented with a rapid growing excrescence that was proposed for biopsy. The anatomopathologic features were consistent with squamous cell carcinoma. The nuclear magnetic resonance revealed a mass on the posterior region, of the right ankle infiltrating deep structures (tendons, muscles, bone). Amputation was performed. Squamous cell carcinoma (SCC) arising in chronic ulcers of leprosy patients is uncommon. Most occur in leprosy-endemic countries (India, Africa and Latin America). In Spain, few cases have been described Marjolin ulcers in patients with leprosy. Marjolin ulcer is a welldefined, but uncommon malignant ulcer that occurs in chronic wounds and cutaneous scars. Most of the tumors are relatively slow growing and tend to metastasize late with an average time of approximately 25 years. Various theories concerning pathogenesis of Marjolin ulcer have been proposed. Well-differentiated squamous cell carcinoma is the most common histological type of Marjolin ulcer. Biopsy with histopathologic interpretation remains the gold standard for the diagnosis, with radical surgical excision being the treatment of choice. Commercial support: None identified.
AB200
J AM ACAD DERMATOL
MAY 2016