Phase II trial of docetaxel, cisplatin and 5FU chemotherapy in locally advanced and metastatic penis cancer (CRUK/09/001).
Authors
Nicholson, SHall, E
Harland, S
Chester, J
Pickering, L
Barber, J
Elliott, Tony
Thomson, A
Burnett, S
Cruickshank, C
Carrington, Bernadette M
Waters, R
Bahl, A
Issue Date
2013-11-12
Metadata
Show full item recordAbstract
Background:Penis cancer is rare and clinical trial evidence on which to base treatment decisions is limited. Case reports suggest that the combination of docetaxel, cisplatin and 5-flurouracil (TPF) is highly active in this disease.Methods:Twenty-nine patients with locally advanced or metastatic squamous carcinoma of the penis were recruited into a single-arm phase II trial from nine UK centres. Up to three cycles of chemotherapy were received (docetaxel 75 mg m(-2) day 1, cisplatin 60 mg m(-2) day 1, 5-flurouracil 750 mg m(-2) per day days 1-5, repeated every 3 weeks). Primary outcome was objective response (assessed by RECIST). Fourteen or more responses in 26 evaluable patients were required to confirm a response rate of 60% or higher (Fleming-A'Hern design), warranting further evaluation. Secondary endpoints included toxicity and survival.Results:10/26 evaluable patients (38.5%, 95% CI: 20.2-59.4) achieved an objective response. Two patients with locally advanced disease achieved radiological complete remission. 65.5% of patients experienced at least one grade 3/4 adverse event.Conclusion:Docetaxel, cisplatin and 5FU did not reach the pre-determined threshold for further research and caused significant toxicity. Our results do not support the routine use of TPF. The observed complete responses support further investigation of combination chemotherapy in the neoadjuvant setting.Citation
Phase II trial of docetaxel, cisplatin and 5FU chemotherapy in locally advanced and metastatic penis cancer (CRUK/09/001). 2013, 109 (10):2554-9 Br J CancerJournal
British Journal of CancerDOI
10.1038/bjc.2013.620PubMed ID
24169355Type
ArticleLanguage
enISSN
1532-1827ae974a485f413a2113503eed53cd6c53
10.1038/bjc.2013.620
Scopus Count
Collections
Related articles
- Phase II study of docetaxel, cisplatin, and fluorouracil in patients with distantly metastatic penile cancer as first-line chemotherapy.
- Authors: Zhang S, Zhu Y, Ye D
- Issue date: 2015 Oct 13
- Neoadjuvant docetaxel, cisplatin and ifosfamide (ITP) combination chemotherapy for treating penile squamous cell carcinoma patients with terminal lymph node metastasis.
- Authors: Xu J, Li G, Zhu SM, Cai QL, Wang Z, Yang X, Zhang HT, Niu YJ
- Issue date: 2019 Jun 25
- Docetaxel, cisplatin, and fluorouracil chemotherapy for metastatic or unresectable locally recurrent anal squamous cell carcinoma (Epitopes-HPV02): a multicentre, single-arm, phase 2 study.
- Authors: Kim S, François E, André T, Samalin E, Jary M, El Hajbi F, Baba-Hamed N, Pernot S, Kaminsky MC, Bouché O, Desrame J, Zoubir M, Ghiringhelli F, Parzy A, De La Fouchardiere C, Smith D, Deberne M, Spehner L, Badet N, Adotevi O, Anota A, Meurisse A, Vernerey D, Taieb J, Vendrely V, Buecher B, Borg C
- Issue date: 2018 Aug
- A two-arm multicenter phase II trial of one cycle chemoselection split-dose docetaxel, cisplatin and 5-fluorouracil (TPF) induction chemotherapy before two cycles of split TPF followed by curative surgery combined with postoperative radiotherapy in patients with locally advanced oral and oropharyngeal squamous cell cancer (TISOC-1).
- Authors: Inhestern J, Schmalenberg H, Dietz A, Rotter N, Maschmeyer G, Jungehülsing M, Grosse-Thie C, Kuhnt T, Görner M, Sudhoff H, Wittekindt C, Guntinas-Lichius O
- Issue date: 2017 Aug 1
- Docetaxel and cisplatin: an active regimen in patients with locally advanced, recurrent or metastatic squamous cell carcinoma of the head and neck. Results of a phase II study of the EORTC Early Clinical Studies Group.
- Authors: Schöffski P, Catimel G, Planting AS, Droz JP, Verweij J, Schrijvers D, Gras L, Schrijvers A, Wanders J, Hanauske AR
- Issue date: 1999 Jan