Etoposide, Methotrexate, and Dactinomycin Alternating With Cyclophosphamide and Vincristine (EMACO) for Male Patients With HCG-expressing, Chemoresistant Germ Cell Tumors.

Daniele Raggi, Patrizia Giannatempo, Rosalba Miceli, Elena Fare', Luigi Piva, Davide Biasoni, Mario Catanzaro, Tullio Torelli, Silvia Stagni, Manuela Marongiu, Alessandro M. Gianni, Nicola Nicolai, Roberto Salvioni, Andrea Necchi

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Abstract

OBJECTIVES: To retrospectively analyze the efficacy and safety results of the combination of methotrexate, dactinomycin, cyclophosphamide, and vincristine (EMACO) regimen for patients with human chorionic gonadotropin (HCG)-producing germ cell tumors and who had failed multiple courses of chemotherapy. METHODS: Patients who had failed at least 2 regimens received methotrexate 100 mg/m, followed by methotrexate 200 mg/m over 12 hours day 1, etoposide 100 mg/m and dactinomycin 0.5 mg days 1 and 2, folinic acid 25 mg orally every 6 hours days 2 and 3, alternating with cyclophosphamide 600 mg/m plus vincristine 1 mg/m day 8, every 21 days. Treatment was continued until marker normalization and for additional 2 cycles. Response rate, progression-free (PFS), and overall survival (OS) were the efficacy endpoints. Cox regression analyses examined the prognostic impact of candidate factors on PFS and OS. RESULTS: From February 92 to May 13, 41 patients were treated in third line (n=20, 49 or beyond (n=21, 51. Seventeen (41 had received high-dose chemotherapy. Thirty-one patients (75.6 had a response with marker reduction, including 4 complete (9.8 and 5 (12.2 partial responses with HCG normalization. Median PFS was 3 months (95% confidence interval [CI], 2-4) and median OS was 8 months (95% CI, 6-10). Most frequent grade 3-4 toxicity was hematologic (20 patients, 48.8. One toxic death (cerebral hemorrhage) occurred. On multivariable analysis, the line of treatment (greater than third vs. third) was the only significant predictor of both PFS (hazard ratio: 2.50, 95% CI, 1.20-5.24, P=0.015) and OS (hazard ratio: 3.17, 95% CI: 1.46-6.89, P=0.004). CONCLUSIONS: EMACO is an attractive regimen with acceptable toxicity and could be considered an option for HCG-expressing germ cell tumors whenever multiple relapses occur.
Original languageUndefined/Unknown
Pages (from-to)60-65
Number of pages6
JournalAmerican Journal of Clinical Oncology
Volume40
Issue number1
DOIs
Publication statusPublished - Feb 1 2017

Cite this

@article{ceaa373b9d4f4acabc5dcae1da3d3b11,
title = "Etoposide, Methotrexate, and Dactinomycin Alternating With Cyclophosphamide and Vincristine (EMACO) for Male Patients With HCG-expressing, Chemoresistant Germ Cell Tumors.",
abstract = "OBJECTIVES: To retrospectively analyze the efficacy and safety results of the combination of methotrexate, dactinomycin, cyclophosphamide, and vincristine (EMACO) regimen for patients with human chorionic gonadotropin (HCG)-producing germ cell tumors and who had failed multiple courses of chemotherapy. METHODS: Patients who had failed at least 2 regimens received methotrexate 100 mg/m, followed by methotrexate 200 mg/m over 12 hours day 1, etoposide 100 mg/m and dactinomycin 0.5 mg days 1 and 2, folinic acid 25 mg orally every 6 hours days 2 and 3, alternating with cyclophosphamide 600 mg/m plus vincristine 1 mg/m day 8, every 21 days. Treatment was continued until marker normalization and for additional 2 cycles. Response rate, progression-free (PFS), and overall survival (OS) were the efficacy endpoints. Cox regression analyses examined the prognostic impact of candidate factors on PFS and OS. RESULTS: From February 92 to May 13, 41 patients were treated in third line (n=20, 49 or beyond (n=21, 51. Seventeen (41 had received high-dose chemotherapy. Thirty-one patients (75.6 had a response with marker reduction, including 4 complete (9.8 and 5 (12.2 partial responses with HCG normalization. Median PFS was 3 months (95{\%} confidence interval [CI], 2-4) and median OS was 8 months (95{\%} CI, 6-10). Most frequent grade 3-4 toxicity was hematologic (20 patients, 48.8. One toxic death (cerebral hemorrhage) occurred. On multivariable analysis, the line of treatment (greater than third vs. third) was the only significant predictor of both PFS (hazard ratio: 2.50, 95{\%} CI, 1.20-5.24, P=0.015) and OS (hazard ratio: 3.17, 95{\%} CI: 1.46-6.89, P=0.004). CONCLUSIONS: EMACO is an attractive regimen with acceptable toxicity and could be considered an option for HCG-expressing germ cell tumors whenever multiple relapses occur.",
author = "Daniele Raggi and Patrizia Giannatempo and Rosalba Miceli and Elena Fare' and Luigi Piva and Davide Biasoni and Mario Catanzaro and Tullio Torelli and Silvia Stagni and Manuela Marongiu and Gianni, {Alessandro M.} and Nicola Nicolai and Roberto Salvioni and Andrea Necchi",
year = "2017",
month = "2",
day = "1",
doi = "10.1097/COC.0000000000000113",
language = "Non definita",
volume = "40",
pages = "60--65",
journal = "American Journal of Clinical Oncology",
issn = "0277-3732",
publisher = "Lippincott Williams and Wilkins",
number = "1",

}

TY - JOUR

T1 - Etoposide, Methotrexate, and Dactinomycin Alternating With Cyclophosphamide and Vincristine (EMACO) for Male Patients With HCG-expressing, Chemoresistant Germ Cell Tumors.

AU - Raggi, Daniele

AU - Giannatempo, Patrizia

AU - Miceli, Rosalba

AU - Fare', Elena

AU - Piva, Luigi

AU - Biasoni, Davide

AU - Catanzaro, Mario

AU - Torelli, Tullio

AU - Stagni, Silvia

AU - Marongiu, Manuela

AU - Gianni, Alessandro M.

AU - Nicolai, Nicola

AU - Salvioni, Roberto

AU - Necchi, Andrea

PY - 2017/2/1

Y1 - 2017/2/1

N2 - OBJECTIVES: To retrospectively analyze the efficacy and safety results of the combination of methotrexate, dactinomycin, cyclophosphamide, and vincristine (EMACO) regimen for patients with human chorionic gonadotropin (HCG)-producing germ cell tumors and who had failed multiple courses of chemotherapy. METHODS: Patients who had failed at least 2 regimens received methotrexate 100 mg/m, followed by methotrexate 200 mg/m over 12 hours day 1, etoposide 100 mg/m and dactinomycin 0.5 mg days 1 and 2, folinic acid 25 mg orally every 6 hours days 2 and 3, alternating with cyclophosphamide 600 mg/m plus vincristine 1 mg/m day 8, every 21 days. Treatment was continued until marker normalization and for additional 2 cycles. Response rate, progression-free (PFS), and overall survival (OS) were the efficacy endpoints. Cox regression analyses examined the prognostic impact of candidate factors on PFS and OS. RESULTS: From February 92 to May 13, 41 patients were treated in third line (n=20, 49 or beyond (n=21, 51. Seventeen (41 had received high-dose chemotherapy. Thirty-one patients (75.6 had a response with marker reduction, including 4 complete (9.8 and 5 (12.2 partial responses with HCG normalization. Median PFS was 3 months (95% confidence interval [CI], 2-4) and median OS was 8 months (95% CI, 6-10). Most frequent grade 3-4 toxicity was hematologic (20 patients, 48.8. One toxic death (cerebral hemorrhage) occurred. On multivariable analysis, the line of treatment (greater than third vs. third) was the only significant predictor of both PFS (hazard ratio: 2.50, 95% CI, 1.20-5.24, P=0.015) and OS (hazard ratio: 3.17, 95% CI: 1.46-6.89, P=0.004). CONCLUSIONS: EMACO is an attractive regimen with acceptable toxicity and could be considered an option for HCG-expressing germ cell tumors whenever multiple relapses occur.

AB - OBJECTIVES: To retrospectively analyze the efficacy and safety results of the combination of methotrexate, dactinomycin, cyclophosphamide, and vincristine (EMACO) regimen for patients with human chorionic gonadotropin (HCG)-producing germ cell tumors and who had failed multiple courses of chemotherapy. METHODS: Patients who had failed at least 2 regimens received methotrexate 100 mg/m, followed by methotrexate 200 mg/m over 12 hours day 1, etoposide 100 mg/m and dactinomycin 0.5 mg days 1 and 2, folinic acid 25 mg orally every 6 hours days 2 and 3, alternating with cyclophosphamide 600 mg/m plus vincristine 1 mg/m day 8, every 21 days. Treatment was continued until marker normalization and for additional 2 cycles. Response rate, progression-free (PFS), and overall survival (OS) were the efficacy endpoints. Cox regression analyses examined the prognostic impact of candidate factors on PFS and OS. RESULTS: From February 92 to May 13, 41 patients were treated in third line (n=20, 49 or beyond (n=21, 51. Seventeen (41 had received high-dose chemotherapy. Thirty-one patients (75.6 had a response with marker reduction, including 4 complete (9.8 and 5 (12.2 partial responses with HCG normalization. Median PFS was 3 months (95% confidence interval [CI], 2-4) and median OS was 8 months (95% CI, 6-10). Most frequent grade 3-4 toxicity was hematologic (20 patients, 48.8. One toxic death (cerebral hemorrhage) occurred. On multivariable analysis, the line of treatment (greater than third vs. third) was the only significant predictor of both PFS (hazard ratio: 2.50, 95% CI, 1.20-5.24, P=0.015) and OS (hazard ratio: 3.17, 95% CI: 1.46-6.89, P=0.004). CONCLUSIONS: EMACO is an attractive regimen with acceptable toxicity and could be considered an option for HCG-expressing germ cell tumors whenever multiple relapses occur.

U2 - 10.1097/COC.0000000000000113

DO - 10.1097/COC.0000000000000113

M3 - Articolo

VL - 40

SP - 60

EP - 65

JO - American Journal of Clinical Oncology

JF - American Journal of Clinical Oncology

SN - 0277-3732

IS - 1

ER -