Pilot study of outpatient paclitaxel, carboplatin and gemcitabine for advanced stage epithelial ovarian, peritoneal, and fallopian tube cancer

Micha, John P.; Goldstein, Bram H.; Rettenmaier, Mark A.; Mattison, Julie; Graham, Cheri; Birk, Connie L.; Brown, John V.

doi:10.1016/j.ygyno.2004.05.050

Cited by 19 publications

(14 citation statements)

References 18 publications

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“…A total of 57 women with stage III/IV epithelial ovarian cancer were treated with a primary induction chemotherapy program comprising of TCG according to an IRB-approved protocol [14]. From the original group, 16 subjects were removed from the study following the completion of induction chemotherapy per physician discretion, 12 patients were ineligible to receive maintenance chemotherapy because they did not obtain a complete response, 2 subjects were lost to follow-up, and 1 patient refused to continue.…”

Section: Resultsmentioning

confidence: 99%

“…Gemcitabine (800 mg/m 2 ) of body surface area over 30 min was repeated on day 8. The dose of gemcitabine was reduced to 500 mg/m 2 if the patient developed grade 3 or 4 neutropenia or thrombocytopenia [14]. Patients who achieved a clinically-defined complete response (normal physical examination; normal CT scan of the abdomen/pelvis; normal serum CA-125 antigen level (≤35 U/ml) received a maintenance chemotherapy treatment regimen.…”

Section: Methodsmentioning

confidence: 99%

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Improved Overall Survival with 12 Cycles of Single-Agent Paclitaxel Maintenance Therapy following a Complete Response to Induction Chemotherapy in Advanced Ovarian Carcinoma

Abaid

Goldstein²,

Micha³

et al. 2010

Oncology

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Objectives: Previously reported studies have suggested that maintenance therapy in the treatment of ovarian cancer may provide progression-free survival (PFS) benefits, although they have not discerned a similar impact on patient overall survival (OS). Methods: We examined the long-term PFS and OS of a previous study population consecutively treated with either 3 cycles (group A; n = 13 patients) or 12 cycles (group B; n = 13) of paclitaxel (135 mg/m²; Q21 days) maintenance therapy. Eligible patients received maintenance chemotherapy following a complete response to 6 cycles of primary induction chemotherapy, comprising 6 cycles of carboplatin (AUC = 5), paclitaxel (175 mg/m²), and gemcitabine (800 mg/m²) per protocol. Results: There were statistically significant PFS differences between group A (12 months) and group B (24 months) (p = 0.016). Moreover, the OS in group A was 38 months and 80 months for group B (p = 0.012). Current follow-up for this patient population exceeds 58 months. Conclusions: In the present investigation, 12 cycles of single agent paclitaxel maintenance therapy were associated with improved patient PFS and OS benefits. Despite contradictory reports, paclitaxel-based maintenance therapy may favorably impact both PFS and OS in advanced ovarian cancer patients who obtain a complete response to primary induction chemotherapy.

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Section: Resultsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Improved Overall Survival with 12 Cycles of Single-Agent Paclitaxel Maintenance Therapy following a Complete Response to Induction Chemotherapy in Advanced Ovarian Carcinoma

Abaid

Goldstein²,

Micha³

et al. 2010

Oncology

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“…The paclitaxel-carboplatin-gemcitabine triplet has failed to show benefits over the paclitaxel-carboplatin doublet. [20][21][22] If a patient shows EDR to gemcitabine or if a patient does not show EDR to both paclitaxel and carboplatin, the patient who receives triplet therapy may not show any survival benefit but additional toxicity. Therefore, a patient may benefit from a triplet therapy when the patient does not show EDR to gemcitabine or show EDR to both paclitaxel and carboplatin.…”

Section: Comparison Of Edra Results With Clinical Responsesmentioning

confidence: 99%

Efficacy of taxane and platinum-based chemotherapy guided by extreme drug resistance assay in patients with epithelial ovarian cancer

et al. 2009

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Objective:To evaluate the efficacy of taxane and platinum-based chemotherapy guided by extreme drug resistance assay (EDRA) in patients with epithelial ovarian cancer. Methods: Thirty-nine patients were enrolled, who were diagnosed as epithelial ovarian cancer, tubal cancer or primary peritoneal carcinoma and received both debulking surgery and EDRA in Asan Medical Center between August 2004 and August 2006. Another thirty-nine patients were enrolled, who did not receive EDRA as control. Paclitaxel 175 mg/m 2 and carboplatin AUC 5 were administered as primary combination chemotherapy to both EDRA group and the control group. In the EDRA group, paclitaxel was replaced by docetaxel 75 mg/m 2 if a patient showed extreme drug resistance (EDR) to paclitaxel and not to docetaxel. Carboplatin was replaced by cisplatin 75 mg/m 2 if a patient showed EDR to carboplatin and not to cisplatin. If only one drug showed low drug resistance (LDR), it was allowed to add another drug which showed LDR such as gemcitabine 1,000 mg/m 2 . CT scan was performed every three cycles and CA-125 was checked at each cycle. Results: There was no significant difference in overall response rate between EDRA group and the control group (84.5% vs. 71.8%, p=0.107). However, 93.8% of patients in EDRA group did not show EDR to at least one drug and its response rate was significantly higher than that of the control group (93.3% vs. 71.8%, p=0.023). Conclusion: we could choose a combination of taxane and platinum which did not show EDR and could obtain a good response in the patients with ovarian cancer.

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“…Beginning in July 2002, 57 advanced (stage III/IV) epithelial ovarian cancer patients treated by our group received a primary chemotherapy regimen comprising 6 cycles of carboplatin (AUC = 5), paclitaxel (175 mg/m 2 over 1 h) and gemcitabine (800 mg/m 2 ) every 21 days [11]. Gemcitabine (800 mg/m 2 of body surface area) over 30 min was repeated on day 8.…”

Section: Methodsmentioning

confidence: 99%

“…Our group has previously reported its experience with employing a 12-month maintenance/consolidation paclitaxel strategy in a small group of women with advanced ovarian cancer who had attained a clinical complete response to primary chemotherapy, which was compared to a 3-cycle maintenance/consolidation regimen in a similar patient population [11, 12]. This analysis revealed a major improvement in PFS associated with the maintenance approach, similar to that noted in the SWOG/GOG study [9].…”

Section: Introductionmentioning

confidence: 99%

Improved Survival with Single-Agent Paclitaxel Consolidation/Maintenance Therapy in Advanced Ovarian Carcinoma

et al. 2006

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Objectives: Consolidation/maintenance therapy in the standard management of ovarian cancer remains controversial, primarily due to the unknown impact of this strategy on overall survival. Methods: We examined the survival of a previously reported patient population consecutively treated with either 3 cycles (group A; n = 13 patients) or 12 cycles (group B; n = 13) of single-agent paclitaxel consolidation following 6 cycles of primary induction chemotherapy comprising 6 cycles of carboplatin (AUC = 5), paclitaxel (175 mg/m²) and gemcitabine (800 mg/m²). Results: There were no differences in the 2 patient populations regarding known relevant prognostic factors (age, stage, tumor grade). The median progression-free survival was 11 months for group A and 24 months for group B (p = 0.0062). The median overall survival in group A was 38 months and was not reached in group B (p = 0.0019). Current follow-up for these 2 patient groups exceeds 43 months. Conclusion: We recognize the important limitations of this study, particularly its sample size and nonrandomized nature. However, these data provide support for the conclusion that paclitaxel ‘maintenance/consolidation’ therapy may favorably impact overall and progression-free survival in advanced ovarian cancer patients who achieve an excellent response to primary platinum-based chemotherapy.

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Pilot study of outpatient paclitaxel, carboplatin and gemcitabine for advanced stage epithelial ovarian, peritoneal, and fallopian tube cancer

Cited by 19 publications

References 18 publications

Improved Overall Survival with 12 Cycles of Single-Agent Paclitaxel Maintenance Therapy following a Complete Response to Induction Chemotherapy in Advanced Ovarian Carcinoma

Improved Overall Survival with 12 Cycles of Single-Agent Paclitaxel Maintenance Therapy following a Complete Response to Induction Chemotherapy in Advanced Ovarian Carcinoma

Efficacy of taxane and platinum-based chemotherapy guided by extreme drug resistance assay in patients with epithelial ovarian cancer

Improved Survival with Single-Agent Paclitaxel Consolidation/Maintenance Therapy in Advanced Ovarian Carcinoma

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