Combination Cisplatin-Epirubicin-Paclitaxel Therapy for Metastatic Extramammary Paget's Disease

Hirai, Ikuko; Tanese, Keiji; Nakamura, Yoshio; Ishii, Masako; Kawakami, Yutaka; Funakoshi, Takeru

doi:10.1634/theoncologist.2018-0856

Cited by 24 publications

(29 citation statements)

References 10 publications

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“…Currently, there is no consensus regarding the optimal chemotherapeutic regimen for treatment of metastatic EMPD. Numerous case reports and small retrospective studies have documented the efficacies of several regimens, including low‐dose 5‐fluorouracil + cisplatin (FP), 5‐fluorouracil, epirubicin, carboplatin, vincristine and mitomycin (FECOM) combination, the docetaxel (DTX) + S‐1 regimen and the cisplatin, epirubicin and paclitaxel combination regimen . However, treatment outcomes of these are not necessarily satisfactory.…”

Section: Introductionmentioning

confidence: 99%

“…Numerous case reports and small retrospective studies have documented the efficacies of several regimens, including lowdose 5-fluorouracil + cisplatin (FP), 5-fluorouracil, epirubicin, carboplatin, vincristine and mitomycin (FECOM) combination, the docetaxel (DTX) + S-1 regimen and the cisplatin, epirubicin and paclitaxel combination regimen. [4][5][6][7] However, treatment outcomes of these are not necessarily satisfactory. While low-dose FP and FECOM regimens show median progression-free survival (PFS) of 5.2 and 6.5 months, respectively, both showed median overall survival (OS) of less than 1 year.…”

Section: Introductionmentioning

confidence: 99%

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Weekly docetaxel monotherapy for metastatic extramammary Paget’s disease: Retrospective single‐institute analysis

Nakamura

Tanese

Hirai

et al. 2020

The Journal of Dermatology

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Monthly docetaxel (DTX) monotherapy is the first‐line regimen that is preferably used for metastatic extramammary Paget’s disease (EMPD). However, the high‐dose DTX regimen frequently causes severe hematological adverse events (AE). To overcome such safety concerns, a weekly low‐dose DTX monotherapy has been proposed for use in the treatment of various cancer types. In this study, we aimed to evaluate the feasibility and efficacy of weekly DTX (25 mg/m2) monotherapy for metastatic EMPD by retrospectively analyzing the clinical courses of 14 patients treated with this regimen. Weekly DTX monotherapy was well tolerated and all patients completed the treatment schedule without treatment withdrawal, dose reduction or treatment‐related death. While five cases (35.7%) experienced hematological AE, their severity was mild. The response rate was 35.7% (5/14 cases), which included five partial responses. The mean progression‐free survival (PFS) and overall survival were 7.1 (95% confidence interval [CI], 5.1–9.1) and 26.4 months (95% CI, 16.7–36.1), respectively. Furthermore, the median PFS was 7.3 months (95% CI, 4.5–10.0) in patients aged 65 years and younger and 7.1 months (95% CI, 4.4–9.9) in patients older than 65 years. These results suggest that weekly DTX monotherapy may be a useful regimen that has a high treatment continuation rate with low levels of hematological toxicity, regardless of the patient’s age for metastatic EMPD.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Weekly docetaxel monotherapy for metastatic extramammary Paget’s disease: Retrospective single‐institute analysis

Nakamura

Tanese

Hirai

et al. 2020

The Journal of Dermatology

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“…At present, no chemotherapeutic agents have yet been approved for the treatment of metastatic EMPD. Several cytotoxic chemotherapeutic regimens have been used to treat metastatic EMPD, such as combination of low-dose 5-fluorouracil and cisplatin (FP therapy), combination of 5-fluorouracil, epirubicin, carboplatin, vincristine, and mitomycin C (FECOM therapy), combination of cisplatin, epirubicin and paclitaxel (PET therapy), combination of docetaxel and S-1, docetaxel monotherapy, and S-1 monotherapy (68–76). In general, certain patient populations initially respond well to these therapies.…”

Section: Treatment Of Metastatic Empdmentioning

confidence: 99%

“…Nevertheless, modification of the treatment schedule or improvement of the chemotherapeutic regimen may enhance the efficacy. In PET therapy, adjustment of the dosing interval enabled Japanese metastatic EMPD patients to continue treatment by reducing its severe toxicity, while maintaining its high efficacy (76).…”

Section: Treatment Of Metastatic Empdmentioning

confidence: 99%

Updates on the Systemic Treatment of Advanced Non-melanoma Skin Cancer

et al. 2019

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Non-melanoma skin cancers (NMSCs), which represent a diverse group of cutaneous malignancies, are the most common forms of human neoplasia. The incidence of these diseases is increasing due to a number of factors, including that of increasing human lifespans. The majority of NMSCs are basal cell carcinomas (BCC) and cutaneous squamous cell carcinomas (cSCC), with the remainder being various rare skin cancers, including extramammary Paget's disease (EMPD), Merkel cell carcinoma (MCC), and several skin adnexal carcinomas. Of these, MCC usually shows aggressive behavior with a high mortality rate. On the other hand, BCC, cSCC, EMPD, and skin adnexal tumors usually show an indolent clinical course and metastasize only rarely. Nevertheless, the metastatic forms of these tumors commonly lead to poor patient outcome. A definitive management strategy for the treatment of advanced NMSC has not been established, mainly due to their rarity and lack of reliable information based on well-controlled randomized trials. Chemotherapeutic regimens for treatment of these diseases have been mainly based on the observations of isolated, small case series or clinical trials with a limited numbers of patients. However, accumulating evidence regarding their pathobiological backgrounds as well as recent advances in molecular biotechnology have facilitated the development of novel drugs for treatment of these diseases. Over the past decade, the U.S. Food and Drug Administration has approved several molecular targeting therapies, including Hedgehog inhibitors for BCC, monoclonal antibodies targeting anti-programmed death ligand-1 and anti- programmed cell death 1 (PD-1) for MCC, and anti-PD-1 for cSCC. Here, we review their clinical utility and discuss updated systemic treatment strategies for advanced NMSC.

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“…[ 9 – 16 ] For EMPDs, single-agent taxane, cisplatin, or fluoropyrimidine-based regimens are used. [ 17 – 25 ] Nevertheless, evidence regarding the clinical benefit of these therapies is limited, mainly due to the rarity of these cancers and the challenges involved in the design of well-controlled clinical trials. Conducting clinical studies in patients with adnexal carcinomas is even more challenging, as the incidence of adnexal carcinoma is extremely low.…”

Section: Introductionmentioning

confidence: 99%

Anti-PD-1 antibody therapy for epithelial skin malignancies

et al. 2020

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Introduction: Malignant cutaneous epithelial tumors comprise various skin malignancies originating from the cutaneous epithelium, including cutaneous squamous cell carcinoma, basal cell carcinoma, and malignant cutaneous adnexal tumors. Treatment options are limited, as the rarity of these tumors, especially among Asians, renders well-controlled clinical trials extremely challenging to conduct. Thus, we designed a clinical trial to evaluate the efficacy and safety of the anti-programmed cell death-1 (PD-1) monoclonal antibody nivolumab in patients with metastatic cutaneous squamous cell carcinomas and other rare metastatic cutaneous epithelial tumors. Methods and analysis: This is an open-label, single-arm, multicenter, phase 2 clinical trial involving patients with metastatic malignant cutaneous epithelial tumors. Nivolumab (480 mg) will be administered intravenously every 4 weeks for a maximum of 26 doses. The primary outcome of the study will be the response rate based on response evaluation criteria in solid tumors, version 1.1. Assuming a null hypothesis of a response rate ≤5% and an alternative hypothesis of a 25% response rate, a minimum of 26 patients are required to achieve a 5% two-sided type I error and 80% power based on the exact binomial distribution. Finally, a target cohort size of 30 patients was determined as some patient dropout will be expected. Discussion: This is the first phase 2 clinical trial evaluating the efficacy and safety of the PD-1 inhibitor nivolumab in Asian patients with metastatic malignant cutaneous epithelial tumors. The findings of the study will contribute to the development of novel treatment approaches for patients with rare cutaneous malignancies, which remains an unmet clinical need. Trial registration: Registry number: jRCT 2031190048

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Combination Cisplatin-Epirubicin-Paclitaxel Therapy for Metastatic Extramammary Paget's Disease

Cited by 24 publications

References 10 publications

Weekly docetaxel monotherapy for metastatic extramammary Paget’s disease: Retrospective single‐institute analysis

Weekly docetaxel monotherapy for metastatic extramammary Paget’s disease: Retrospective single‐institute analysis

Updates on the Systemic Treatment of Advanced Non-melanoma Skin Cancer

Anti-PD-1 antibody therapy for epithelial skin malignancies

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