Weekly topotecan in heavily pretreated patients with recurrent epithelial ovarian carcinoma

O’Malley, David M.; Azodi, Masoud; Makkenchery, Anita; Tangir, Jacob; McAlpine, Jessica N.; Kelly, Michael G.; Schwartz, Peter E.; Rutherford, Thomas J.

doi:10.1016/j.ygyno.2005.04.032

Cited by 39 publications

(23 citation statements)

References 35 publications

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“…The ORR of 24% and SD rate of 42% are generally consistent with the rates reported in retrospective studies of weekly topotecan in relapsed ovarian cancer [11,13,16]. Response rates associated with the standard topotecan regimen in patients with platinum-sensitive ovarian cancer range from 19% to 33%, and SD rates range from 17% to 48% [18,23,24].…”

Section: Discussionsupporting

confidence: 81%

“…However, the low dose of weekly topotecan and continuous infusion schedule used in that trial may have affected the efficacy of topotecan [25]. Similar to results in the current trial, retrospective studies of 2.5 mg/m 2 to 3.7 mg/m 2 weekly topotecan in heavily pretreated patients with ovarian cancer, approximately 50% of whom had potentially platinum-sensitive disease, demonstrated an ORR of 18% to 31%; additionally, 38% to 43% of patients achieved SD [13,16]. Moreover, in a small phase II trial, 4 mg/m 2 weekly topotecan was associated with anORR of almost 50%, with similar response rates for platinum-sensitive and platinumresistant disease [15].…”

Section: Discussionsupporting

confidence: 70%

“…Intermittent dosing schedules in murine models, which simulate weekly dosing in humans, appear to maintain potential therapeutic benefit [8], and recent clinical data have shown that weekly topotecan is not only clinically active but also has a hematologic toxicity profile that compares favorably with that reported for the standard 5-day regimen in patients with relapsed ovarian cancer [13][14][15][16][17]. Additionally, like other agents used in the recurrent setting, topotecan is especially efficacious in platinum-sensitive disease [18].…”

Section: Introductionmentioning

confidence: 99%

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Topotecan weekly bolus chemotherapy for relapsed platinum-sensitive ovarian and peritoneal cancers

Morris

Alvarez

Andrews

et al. 2008

Gynecologic Oncology

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Objective-Topotecan at a dose of 1.5 mg/m 2 on days 1 to 5 of a 21-day cycle is an approved therapy for recurrent ovarian cancer. However, heavily pretreated patients may be predisposed to hematologic adverse events. This prospective study, therefore, investigates the safety and efficacy of an alternate weekly schedule of topotecan in patients with recurrent ovarian or peritoneal cancer.Methods-Patients with potentially platinum-sensitive recurrent ovarian or peritoneal cancer were treated with 4.0 mg/m 2 weekly topotecan as tolerated until disease progression. Antitumor response and safety were assessed. Dose reductions, delays, or omissions were implemented for grades 3-4 adverse events.Results-Of the 41 enrolled patients (median age, 62 years; range, 42 to 82 years), 39 patients had ovarian cancer, and 2 patients had peritoneal cancer. The median platinum-free interval was 11.7 months. A median of 9 topotecan cycles (range, 1 to 45 doses) was administered. Weekly topotecan was well tolerated: 7 (17%) patients had grades 3-4 neutropenia, and 9 (22%) had grades 3-4 fatigue. No grade 4 thrombocytopenia or anemia was reported. Of 38 responseevaluable patients, 1 (3%) had a complete response, 8 (21%) had a partial response, 16 (42%) had stable disease, and 13 (34%) had progressive disease.Conclusions-Weekly topotecan was well tolerated in patients with platinum-sensitive ovarian or peritoneal cancer at first relapse, with a hematologic profile that compared favorably with that of the 5-day topotecan regimen. Moreover, antitumor activity was similar to that reported for the 5-day regimen.

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Section: Discussionsupporting

confidence: 81%

Section: Discussionsupporting

confidence: 70%

Section: Introductionmentioning

confidence: 99%

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Topotecan weekly bolus chemotherapy for relapsed platinum-sensitive ovarian and peritoneal cancers

Morris

Alvarez

Andrews

et al. 2008

Gynecologic Oncology

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“…[7][8][9][10][11][12][13][14] Whereas definitive Phase III study results regarding the modified schedules are lacking, available published data in the peer-reviewed literature demonstrate similar efficacy and substantially less toxicity associated with the use of these palliative chemotherapy agents with the doses and schedules adapted for current standard clinical use.…”

Section: Examplementioning

confidence: 99%

Informing prospective research subjects of the influence of regulatory requirements for drug approval on the design of clinical trials in oncology

Markman

2007

Cancer

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An established tenet of ethical clinical research stipulates that individuals considered for entry into therapeutic trials must be provided with all data that might influence their decision. However, discussion in the literature regarding the investigators' responsibility to inform possible participants about the nature and impact of regulatory requirements on the studies' design has been limited. Three examples are discussed, which illustrate the ethical concerns that might result from the failure of clinical researchers to fully inform patients.

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“…Several phase I–II studies of weekly bolus topotecan in second- and third-line patients with ovarian cancer demonstrated no grade 3–4 haematologic toxicities at doses of 3.5–4.5 mg/m 2 [7,8,9,10,11,12]. …”

Section: Introductionmentioning

confidence: 99%

Phase II Study on Weekly Bolus Topotecan in Advanced or Recurrent Cervical Cancer

Lorusso¹,

Mainenti²,

Pietragalla³

et al. 2011

Oncology

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Objective: It was the aim of our study to evaluate the efficacy and safety of weekly topotecan in patients with advanced or recurrent cervical disease. Methods: Topotecan was administered intravenously as a weekly infusion at a dose of 3.5 mg/m² on days 1, 8 and 15 of a 28-day cycle. After the second cycle, the dose was increased to 4 mg/m² if no grade >2 toxicity occurred. Treatment was continued until disease progression or unacceptable toxicity. Results: Twenty-one patients were enrolled, but only 18 were evaluable for response and toxicity. Ten patients (56%) had received primary surgery + chemoradiation, 6 patients (33%) had previously received surgery + chemotherapy and 2 patients (11%) exclusive chemoradiation. Patients received a mean of 3.5 courses (range 1–6). No complete or partial responses were reported. Two patients (11%) presented disease stabilization as maximum response. Median progression-free survival was 11 weeks (95% CI 15–25), and median overall survival was 28 weeks (95% CI 24–72). The treatment was generally well tolerated. Conclusions: This trial did not report any activity of weekly bolus topotecan in the treatment of advanced or recurrent cervical cancer. Actually, there is no evidence to recommend this therapy in this patient population.

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Weekly topotecan in heavily pretreated patients with recurrent epithelial ovarian carcinoma

Cited by 39 publications

References 35 publications

Topotecan weekly bolus chemotherapy for relapsed platinum-sensitive ovarian and peritoneal cancers

Topotecan weekly bolus chemotherapy for relapsed platinum-sensitive ovarian and peritoneal cancers

Informing prospective research subjects of the influence of regulatory requirements for drug approval on the design of clinical trials in oncology

Phase II Study on Weekly Bolus Topotecan in Advanced or Recurrent Cervical Cancer

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