A phase II study of gemcitabine in platinum pre-treated patients with advanced epithelial ovarian cancer

Friedlander, Michael; Millward, Michael; Bell, David R.; Bugat, R.; Harnett, Paul; Moreno, J.A.; Campbell, Lauren; Varette, C.; Ripoche, Veronique; Kayitalire, L.

doi:10.1023/a:1008469212268

Cited by 132 publications

(61 citation statements)

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“…In a small study of chemonaive patients, single-agent gemcitabine produced a modest overall response rate of 18% (D'Agostino et al, 2003). In patients with platinumpretreated, relapsed ovarian cancer, response rates ranged from 13 to 28%, which are comparable with those of other agents (e.g., topotecan, liposomal doxorubicin, and paclitaxel) in a similar patient population (Lund et al, 1994;Shapiro et al, 1996;Friedlander et al, 1998;Silver and Piver, 1999;von Minckwitz et al, 1999;Underhill et al, 2001). Gemcitabine is generally well tolerated with common toxicities including myelosuppression, lethargy, flu-like symptoms, peripheral oedema, and skin rashes.…”

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confidence: 91%

A phase II feasibility study of carboplatin followed by sequential weekly paclitaxel and gemcitabine as first-line treatment for ovarian cancer

et al. 2004

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A total of 53 women with chemotherapy-naïve stage Ic-IV ovarian cancer were treated with four cycles of carboplatin area under the curve 7 every 3 weeks, followed by four cycles of paclitaxel 70 mg m À2 (days 1, 8, and 15) and gemcitabine 1000 mg m À2 (days 1 and 8) every 3 weeks. In all, 37 (70%) had stage III/IV disease, with 22 (42%) having tumour 42 cm; 38 patients (72%) completed all planned treatment; 27 of the 32 (84%) patients with radiologically evaluable disease had partial or complete responses; and 30 of the 39 patients (77%) with elevated cancer antigen (CA) 125 had a greater than 75% fall in this value. At a median follow-up of 28 months, 31 patients had relapsed with a median progression-free survival of 19.5 months. In total, 79% of patients were alive at 2 years. Common Toxicity Criteria grade 3/4 haematological toxicity, predominantly neutropenia, was seen in 57% of the patients. A certain degree of pulmonary toxicity was observed; eight patients had symptomatic breathlessness, 7 decreased diffusing capacity of the lung for carbon monoxide, and interstitial chest X-ray changes during the weekly phase. In all cases, this toxicity was reversible. No significant neurotoxicity was seen. This regimen is generally well tolerated with encouraging efficacy. However, the observation of pulmonary toxicity, potentially a feature of the weekly taxane -gemcitabine regimen, was of some concern. Alternative schedules, including 3-weekly taxanes, are currently being evaluated.

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confidence: 91%

A phase II feasibility study of carboplatin followed by sequential weekly paclitaxel and gemcitabine as first-line treatment for ovarian cancer

et al. 2004

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“…This may lie on multiple factors. First, some studies strictly included only patients with platinum-free interval <6 months (platinumresistant) when the RRs were only 6-18% ( DOI:http://dx.doi.org/10.7314/APJCP.2014.15.13.5215 Treatment Outcomes with Gemcitabine for Refractory or Recurrent Ovarian Cancer others included heterogeneous group of patients with platinum-free interval ranging from <6 months or <12 months altogether when the RRs were 12-29% (Shapiro et al, 1996;Friedlander et al, 1998;D'Agostino et al, 2003;Ferrandina et al, 2008;Suprasert et al, 2012;Yoshino et al, 2012). Second, the status of platinum-resistance in these studies may be primary after first-line platinum drug or secondary after platinum re-induction.…”

Section: Discussionmentioning

confidence: 99%

“…Third was the regimen of gemcitabine. Some studies found RRs of 6-29% from single agent (Shapiro et al, 1996;Friedlander et al, 1998;D'Agostino et al, 2003;Markman et al, 2003;Mutch et al, 2007;Ferrandina et al, 2008;Watanabe et al, 2008;Suprasert et al, 2012;Yoshino et al, 2012) while others could demonstrate RRs of 13-70% from gemcitabine in combination with platinum or other agents (Greggi et al, 2001;Sehouli et al, 2002;Nagourney et al, 2003;Rose et al, 2003;Garcia et al, 2004;Papadimitriou et al, 2004;Ferrandina et al, 2005;Brewer et al, 2006;Pfisterer et al, 2006;Poole et al, 2006;Bozas et al, 2007). Another reason which might be under-recognized was the setting when gemcitabine was used or numbers of prior chemotherapy.…”

Section: Discussionmentioning

confidence: 99%

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Treatment Outcomes of Gemcitabine in Refractory or Recurrent Epithelial Ovarian Cancer Patients

Chanpanitkitchot

Tangjitgamol²,

Khunnarong³

et al. 2014

Asian Pacific Journal of Cancer Prevention

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Background: To study the response rate (RR), progression-free survival (PFS) and toxicity profiles of recurrent epithelial ovarian cancer (EOC) patients treated with gemcitabine. Materials and Methods: Recurrent EOC patients who were treated with gemcitabine between January 2000 and December 2013 at the Department of Obstetrics and Gynecology, Faculty of Medicine Vajira Hospital were identified and medical records were reviewed. Clinico-pathological features including data of gemcitabine treatment, response and toxicity were collected. Results: We identified 43 EOC patients who had gemcitabine treatment. All except one patient who did not receive any adjuvant treatment, had received platinum-based chemotherapy. Among these 42 patients, 31.0% had refractory cancer to first-line chemotherapy while 69.0% had recurrence with 48.8% being platinumsensitive. The total cycles of gemcitabine used were 203 (median 4, range 2-9 cycles). Overall RR was 11.6%: 19% in platinum-sensitive vs 4.5% in platinum-resistant groups (p=0.158) and 42.9% in the patients having gemcitabine together with platinum vs 5.6% using gemcitabine alone (P=0.024). Median PFS was 3.6 months (95% confidence interval [CI], 2.73-4.49 months): 8.1 months (95% CI, 2.73-4.49 months) in combination regimen vs 3.2 months (95% CI, 2.01-4.42 months) in single regimen (p=0.077) and 8.1 months (95% CI, 4.73-11.48 months) with the gemcitabine combination vs 2.7 months (95% CI, 1.98-3.38 months) by single gemcitabine in platinum sensitive patients (P=0.007). Common toxicities were hematologic which were well tolerated and manageable. Conclusions: Gemcitabine has modest activity in pre-treated EOC. A combination regimen had higher activity than single agent in platinum sensitive patients with a significant improvement in RR and PFS.

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“…There are a number of chemotherapy options including liposomal doxorubicin [81], topotecan [81], etoposide [82,83], and gemcitabine [84,85]. The reported response rates are low, about 10%, with a median time to progression of 3-4 months and a median survival of 9-12 months.…”

Section: Chemotherapy For Recurrent Epithelial Malignanciesmentioning

confidence: 99%

Cancer of the ovary, fallopian tube, and peritoneum

Berek

Crum

Friedlander

2015

Intl J Gynecology & Obste

125

119

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A phase II study of gemcitabine in platinum pre-treated patients with advanced epithelial ovarian cancer

Abstract: Single-agent gemcitabine is active and well tolerated in patients with recurrent ovarian cancer.

Cited by 132 publications

References 13 publications

A phase II feasibility study of carboplatin followed by sequential weekly paclitaxel and gemcitabine as first-line treatment for ovarian cancer

A phase II feasibility study of carboplatin followed by sequential weekly paclitaxel and gemcitabine as first-line treatment for ovarian cancer

Treatment Outcomes of Gemcitabine in Refractory or Recurrent Epithelial Ovarian Cancer Patients

Cancer of the ovary, fallopian tube, and peritoneum

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