title: Paclitaxel+BEP (T-BEP) regimen as induction chemotherapy in poor prognosis patients with nonseminomatous germ cell tumors: a phase II study.
abstract: OBJECTIVE
  To evaluate paclitaxel, bleomycin, etoposide, and cisplatin (T-BEP) in patients with poor-prognosis nonseminomatous germ cell tumor (NSGCT). Paclitaxel is an active treatment of nonseminomatous germ cell tumors.
  
  
  METHODS
  The present study was an open-label, single-center, Phase II study. Chemotherapy-naive patients received T-BEP (paclitaxel 175 mg/m2 [day 2], cisplatin 20 mg/m2 [days 1-5], etoposide 100 mg/m2 [days 1-5], bleomycin 30 IU [days 1, 3, and 5]), and granulocyte colony-stimulating factor 300 μg (days 6-10). The number of cycles (range 4-6) was dependent on the normalization of tumor markers. Secondary resection was planned for patients with tumor marker-negative partial remission. Assessments included radiologic response, tumor markers, and safety. The primary endpoint was progression-free survival (PFS) 1 year after chemotherapy.
  
  
  RESULTS
  Of 51 patients, 49 completed chemotherapy and were evaluable for response: 12 (25%) had a complete response, 29 (59%) were marker-negative (tumor marker normalization) and 3 (6%) were marker-positive (tumor marker decrease for ≥1 month) incomplete responders, and 5 (10%) had progressive disease. A total of 37 patients underwent secondary resection. After the treatment of 27 patients, an unplanned analysis showed inappropriate toxicity at cycle 1 (grade 3-4 infection [6 patients] resulting in 2 toxic deaths), which led to treatment modification (BEP [cycle 1], T-BEP [subsequent cycles]), with no further toxic deaths observed. Grade 3-4 adverse events included neutropenia (71%), febrile neutropenia (33%), and infection (14%). During the first year after chemotherapy, 1 patient was lost to follow-up, and 21 patients relapsed. The PFS rate at 1 year after chemotherapy was 58% (29 of 50 patients).
  
  
  CONCLUSIONS
  T-BEP did not improve PFS in patients with poor-prognosis NSGCT. The administration of T-BEP from cycle 1 resulted in excessive toxicity but was administered safely from cycle 2.
authors.affiliation: Department of Clinical Pharmacology and Chemotherapy, NN Blokhin Russian Cancer Research Center, Moscow, Russia. atryakin@mail.ru
authors.forename: A
authors.initials: A
authors.lastname: Tryakin
authors.forename: M
authors.initials: M
authors.lastname: Fedyanin
authors.forename: D
authors.initials: D
authors.lastname: Kanagavel
authors.forename: I
authors.initials: I
authors.lastname: Fainstein
authors.forename: J
authors.initials: J
authors.lastname: Sergeev
authors.forename: B
authors.initials: B
authors.lastname: Polockij
authors.forename: V
authors.initials: V
authors.lastname: Matveev
authors.forename: T
authors.initials: T
authors.lastname: Zakharova
authors.forename: A
authors.initials: A
authors.lastname: Garin
authors.forename: S
authors.initials: S
authors.lastname: Tjulandin
mesh_terms: D000293:Adolescent; D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001761:Bleomycin / Q000008:administration & dosage / Q000009:adverse effects; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D005047:Etoposide / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D008297:Male; D008479:Mediastinal Neoplasms / Q000188:drug therapy*; D008875:Middle Aged; D009373:Neoplasms, Germ Cell and Embryonal / Q000188:drug therapy* / Q000556:secondary; D011379:Prognosis; D013736:Testicular Neoplasms / Q000188:drug therapy*; D055815:Young Adult
chemical_list: D001761:Bleomycin; D005047:Etoposide; D002945:Cisplatin