An update of a phase II study of paclitaxel in advanced or recurrent squamous cell cancer of the cervix

Kudelka, Andrzej P.; Winn, Rodger J.; Edwards, Creighton L.; Downey, Gabrielle; Greenberg, Harvey; Dakhil, Shaker R.; Freedman, Ralph S.; Lococo, Salvatore; Umbreit, Jay N.; Delmore, James E.; Arbuck, Susan G.; Loyer, Evelyne M.; Gacrama, Patsy; Fueger, Rebecca; Kavanagh, John J.

doi:10.1097/00001813-199708000-00002

Cited by 57 publications

(24 citation statements)

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“…Paclitaxel represents an established active cytotoxic agent against advanced/metastatic cervical cancer at doses between 170 and 250 mg m À2 (McGuire et al, 1996;Kudelka et al, 1997). Ifosfamide represents an oxazaphosphorine alkylating agent that has yielded an 11% RR in pretreated and a 15.7% RR in chemotherapy-naive patients with advanced cervical cancer, whereas at high doses of 3.5 g m À2 Â 5 days, a 50% RR in untreated patients was observed (Cervellino et al, 1990).…”

Section: Discussionmentioning

confidence: 99%

“…Beyond its early documented activity in relapsed ovarian cancer (Eisenhauer et al, 1994), there are a small number of studies confirming its activity in advanced endometrial carcinoma (Lissoni et al, 1996). Single-agent paclitaxel has shown an initial 17% activity in advanced cervical cancer at a dose of 170 mg m À2 in 24-h infusion (Thigpen et al, 1995;McGuire et al, 1996), whereas subsequent doses of 250 mg m À2 over 3 h with granulocyte-colony stimulating factor (G-CSF) support yielded response rates (RRs) of 25% (Kudelka et al, 1997). Until now, cisplatin has been the most active cytotoxic drug in advanced cervical cancer, and randomised studies applying combinations of first-generation cytotoxic agents with cisplatin had not shown any advantage over single-agent cisplatin.…”

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confidence: 99%

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Evaluation of the paclitaxel–ifosfamide–cisplatin (TIP) combination in relapsed and/or metastatic cervical cancer

et al. 2009

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BACKGROUND: Recurrent or metastatic cervical cancer represents an aggressive malignancy with a high rate of locoregional and distant failure. Therefore, we evaluated the three-drug combination of paclitaxel -ifosfamide -cisplatin (TIP). METHODS: Systemic chemotherapy-naive patients with advanced metastatic/relapsed cervical cancer and a World Health Organization (WHO) performance status (PS) of 0 -2 were eligible. TIP chemotherapy doses were paclitaxel 175 mg m À2 on day 1, ifosfamide 2.5 g m À2 on days 1 þ 2, and cisplatin 40 mg m À2 on days 1 þ 2, with prophylactic granulocyte-colony stimulating factor. RESULTS: A total of 42 patients with recurrent/metastatic cervical cancer are evaluable for response and toxicity: median age: 56 (25 -74) years; PS: 1 (0 -2); histologies -squamous: 35, adenosquamous: 5, and adenocarcinoma: 2. Responses were overall response rate (RR): 62% (95% confidence interval (CI): 47.3 -76.7%), with complete response (CR): 26% (95% CI: 12.7 -39.3%), and partial response (PR): 36% (95% CI: 21.5 -49.9%). Responses according to the relapse site were overall RR: 32% (95% CI: 13.7 -50.3%) within previously irradiated pelvis vs 75% (95% CI: 57.7 -92.3%) in extra-pelvic sites. Median time to progression (TTP) was 7 (range, 2 -34 þ ) months and median overall survival (OS) was 16.5 (range, 3 -36 þ ) months. Toxicities included grade 3 -4 neutropenia: 83% (21% febrile neutropenia), grade 3 -4 thrombocytopenia: 9%, no grade 3 neuropathy (35% grade 2), grade 2 asthenia/fatigue 15%, and no treatment-related deaths. CONCLUSION: TIP is an active regimen with acceptable toxicity in advanced/relapsed cervical cancer.

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Section: Discussionmentioning

confidence: 99%

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confidence: 99%

Evaluation of the paclitaxel–ifosfamide–cisplatin (TIP) combination in relapsed and/or metastatic cervical cancer

et al. 2009

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“…However, one could note that in at least 3 of the phase I studies that included paclitaxel, severe diarrhoea was the limiting toxicity which agrees with our findings. [27,28] However, because of the small size of the study it was not possible to fully evaluate the influence of these factors either separately or all combined.…”

Section: Patient's Characteristics Listed Inmentioning

confidence: 99%

A Comparative Evaluation of Radiotherapy With Concurrent Weekly Cisplatin Versus Concurrent Weekly Paclitaxel in Patients With Locally Advanced Carcinoma Cervix

Maurya¹,

Singotia²,

Saxena³

et al. 2016

jemds

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OBJECTIVESA prospective study to compare weekly cisplatin versus weekly paclitaxel as concurrent chemotherapy with standard radiotherapy in locally advanced carcinoma cervix. METHODSThe study was carried out between November 2013 and August 2104; 60 newly diagnosed women with histopathologically proven squamous cell carcinoma cervix (FIGO stage IB2 to IVA were enrolled into this study and randomized to receive on weekly basis either 40 mg/m 2 cisplatin (Control Group: 30 patients) or 50 mg/m 2 paclitaxel (Study Group: 30 patients) concurrently with radiotherapy total dose for radiotherapy 80 Gy for both the groups (50 Gy from EBRT and 30 Gy from HDR brachytherapy). Followup time was 6 months. RESULTSThe mean number of chemotherapy cycles was comparable with 86.7% and 80% of patients receiving 5 doses in control and study group respectively. At the completion of treatment 20 patients (66.7%) in control group and 15 patients (50%) in study group had complete response; 10 patients (33.3%) in control group and 15 patients (50%) in study group had partial response. After 6 months of followup, 23 patients (76.7%) in control group and 19 (63.3%) patients of study group had complete response and 7 (23.4%) patients of control group and 10 (33.4%) patients of study group had partial response respectively. One patient of study group developed progressive disease during followup period. CONCLUSIONThis small prospective study shows that weekly paclitaxel does not provide any clinical advantage over weekly cisplatin for concurrent chemoradiation for locally advanced carcinoma cervix and associated with more gastrointestinal and haematological toxicities.

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“…Further, because persistent and recurrent cervical cancer are not usually responsive to reirradiation, first-line treatment offers the best possibility for a cure. Therefore, several new cytotoxic agents have been recently investigated in the first-line treatment of cervical cancer patients (Table 1) [18][19][20][21][22][23]. In chemotherapynaïve patients with advanced or recurrent squamous cervical carcinoma, treatment with paclitaxel 170-250 mg/m 2 results in a response rate of 17%-23% [18,19].…”

Section: Current First-line Treatment Strategiesmentioning

confidence: 99%

“…Therefore, several new cytotoxic agents have been recently investigated in the first-line treatment of cervical cancer patients (Table 1) [18][19][20][21][22][23]. In chemotherapynaïve patients with advanced or recurrent squamous cervical carcinoma, treatment with paclitaxel 170-250 mg/m 2 results in a response rate of 17%-23% [18,19]. Treatment with weekly vinorelbine 30 mg/m 2 in previously untreated patients with recurrent cervical cancer resulted in an overall response rate (ORR) of 45% [23].…”

Section: Current First-line Treatment Strategiesmentioning

confidence: 99%

Update on the Treatment of Cervical and Uterine Carcinoma: Focus on Topotecan

Fiorica

2002

The Oncologist

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An update of a phase II study of paclitaxel in advanced or recurrent squamous cell cancer of the cervix

Cited by 57 publications

References 0 publications

Evaluation of the paclitaxel–ifosfamide–cisplatin (TIP) combination in relapsed and/or metastatic cervical cancer

Evaluation of the paclitaxel–ifosfamide–cisplatin (TIP) combination in relapsed and/or metastatic cervical cancer

A Comparative Evaluation of Radiotherapy With Concurrent Weekly Cisplatin Versus Concurrent Weekly Paclitaxel in Patients With Locally Advanced Carcinoma Cervix

Update on the Treatment of Cervical and Uterine Carcinoma: Focus on Topotecan

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