A Phase II Trial of TIP (Paclitaxel, Ifosfamide and Cisplatin) Given as Second-Line (Post-BEP) Salvage Chemotherapy for Patients With Metastatic Germ Cell Cancer: A Medical Research Council Trial

Mead, GM; Cullen, Michael; Huddart, Robert; Harper, Peter; Gj, Rustin; Cook, Pat; Stenning, S; Mason, Malcolm

doi:10.1016/s0022-5347(05)01045-1

Cited by 23 publications

(37 citation statements)

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“…170,171,173,[175][176][177][178][179] With these regimens, long-term disease control can be achieved in between 15% to 60% of patients. Given that no randomized trials exist comparing these chemotherapy combinations, no recommendation can be made as to which regimen is superior or should be used as the standard management.…”

Section: Standard Dose Chemotherapymentioning

confidence: 99%

Canadian consensus guidelines for the management of testicular germ cell cancer

Wood

Kollmannsberger

Jewett

et al. 2013

CUAJ

123

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Section: Standard Dose Chemotherapymentioning

confidence: 99%

Canadian consensus guidelines for the management of testicular germ cell cancer

Wood

Kollmannsberger

Jewett

et al. 2013

CUAJ

123

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“…The mainstay TGCT treatment over the last decades has been platinum-based chemotherapy associated with surgery, leading to high response rates and also in some cases to a curable disease [11]. Nevertheless, the development of refractory disease is still a challenge in around 15 % of the cases, and even within this group, there is a large range of risk [12,13]. Currently, the risk stratification of the patients is based only on clinical parameters as the spreading pattern and serum levels of human chorionic gonadotropin (hCG), alpha-fetoprotein (AFP), and lactate dehydrogenase (LDH).…”

Section: Introductionmentioning

confidence: 99%

Hotspot TERT promoter mutations are rare events in testicular germ cell tumors

et al. 2015

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The abnormal activation of telomerase, codified by the telomerase reverse transcriptase (TERT) gene, is related to one of cancer hallmarks. Hotspot somatic mutations in the promoter region of TERT, specifically the c.-124:C>T and c.-146:C>T, were recently identified in a range of human cancers and have been associated with a more aggressive behavior. Testicular germ cell tumors frequently exhibit a good prognosis; however, the development of refractory disease is still a clinical challenge. In this study, we aim to evaluate for the first time the presence of the hotspot telomerase reverse transcriptase gene promoter mutations in testicular germ cell tumors. A series of 150 testicular germ cell tumor cases and four germ cell tumor cell lines were evaluated by PCR followed by direct Sanger sequencing and correlated with patient's clinical pathological features. Additionally, we genotyped the telomerase reverse transcriptase gene promoter single nucleotide polymorphism rs2853669 (T>C) located at −245 position. We observed the presence of the TERT promoter mutation in four patients, one exhibited the c.-124:C>T and three the c.-146:C>T. No association between TERT mutation status and clinicopathological features could be identified. The analysis of the rs2853669 showed that variant C was present in 22.8 % of the cases. In conclusion, we showed for the first time that TERT promoter mutations occur in a small subset (~3 %) of testicular germ cell tumors.

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“…[7][8][9][10] Paclitaxelcontaining therapy, such as TIP therapy, has shown a particularly good response rate and longer survival in first relapses of GCT. 11,12 The National Comprehensive Cancer Network guideline recommends TIP therapy as a second-line chemotherapy in cases with good prognostic features. 13 However, in cases with poor prognostic features, such as cisplatin resistance or multiple relapses after cisplatin-based chemotherapy, the prognosis has remained poor.…”

Section: Introductionmentioning

confidence: 99%

Salvage combined chemotherapy with paclitaxel, ifosfamide and nedaplatin for patients with advanced germ cell tumors

et al. 2014

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Abbreviations & Acronyms AE = adverse events AFP = alpha-feto protein BEP = bleomycin, etoposide and cisplatin CINV = chemotherapy-induced nausea and vomiting CR = complete response GCT = germ cell tumor HCG = human chorionic gonadotropin HDCT = high-dose chemotherapy IGCCCG = International Germ Cell Cancer Collaborative Group LN = lymph node NED = no evidence of disease NC = no change of visible disease NCm-= no change of visible disease with serum tumor marker normalization NCm+ = no change of visible disease without serum tumor marker normalization OS = overall survival PD = progressive disease PFS = progression-free survival PR = partial response PRm-= partial response with marker normalization PRm+ = partial response without marker normalization PTX = paclitaxel RPLND = retroperitoneal lymph node dissection STM = serum tumor marker TIN = paclitaxel, ifosfamide and nedaplatin TIP = paclitaxel, ifosfamide and cisplatin TRD = treatment-related deaths VeIP = vinblastine, ifosfamide and cisplatin VIP = etoposide, ifosfamide and cisplatin Objectives: To investigate the efficacy of combined regimen with paclitaxel, ifosfamide and nedaplatin as salvage chemotherapy in patients with cisplatin-refractory or multiple relapsed germ cell tumors. Methods: A total of 65 patients refractory to cisplatin-based chemotherapy or with relapse after induction or salvage chemotherapy received paclitaxel 210 mg/m 2 on day 1, ifosfamide 1.2 g/m 2 on days 2-6 and nedaplatin 100 mg/m 2 on day 2 of a 3-week cycle. The primary and secondary end-points were the response rate and overall survival, respectively. Results: Paclitaxel, ifosfamide and nedaplatin therapy was carried out as second-line therapy in 17 patients, third-line in 31 and fourth-line or later in 17. Patients were pretreated with a median of six cycles of platinum-based chemotherapy (range 3-15 cycles). The overall response rate was 62.9%, including one patient with complete response and 38 with partial response. Serum tumor marker levels normalized in 35 (56.5%) patients. Overall survival at a median follow up of 34 months was 59.3%, and median time to progression was 12 months. Multivariate analysis showed that serum tumor marker normalization was the only independent predictor of better progression-free survival and overall survival. Grade 3/4 of neutropenia, anemia and thrombocytopenia was observed in 96.9%, in 81.5%, and in 90.8% of patients, respectively. Conclusion: Paclitaxel, ifosfamide and nedaplatin chemotherapy appears to be effective when used as first or second salvage treatment in advanced relapsed germ cell tumors. Even after fourth-line therapy, patients with serum tumor marker normalization might have a chance for a cure.

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A Phase II Trial of TIP (Paclitaxel, Ifosfamide and Cisplatin) Given as Second-Line (Post-BEP) Salvage Chemotherapy for Patients With Metastatic Germ Cell Cancer: A Medical Research Council Trial

Cited by 23 publications

References 0 publications

Canadian consensus guidelines for the management of testicular germ cell cancer

Canadian consensus guidelines for the management of testicular germ cell cancer

Hotspot TERT promoter mutations are rare events in testicular germ cell tumors

Salvage combined chemotherapy with paclitaxel, ifosfamide and nedaplatin for patients with advanced germ cell tumors

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