Long-term follow-up confirms a survival advantage of the paclitaxel–cisplatin regimen over the cyclophosphamide–cisplatin combination in advanced ovarian cancer

Piccart, M.; Bertelsen, K.; Stuart, Gavin; Cassidy, J.; Mangioni, C.; Simonsen, Erik B.; James, Keith; Kaye, Samantha L.; Vergote, Ignace; Blom, René; Grimshaw, Robert; Atkinson, R.; Swenerton, K.; Tropé, Claes G.; Nardi, Mario; Kærn, J.; Tumolo, Salvatore; Timmers, Petra; Roy, Josée-Anne; Lhoas, F.; Lidvall, B.; Bacon, Monica; Birt, A.; Andersen, Johan A.; Zee, B.; Paul, J. P.; Pecorelli, Sërgio; McGuire, William P.

doi:10.1136/ijgc-00009577-200311001-00003

Cited by 42 publications

(33 citation statements)

References 6 publications

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“…Overall survival and DFS at 7 years are similar to those presented in the literature for first-line therapy with paclitaxel (24) , thus casting doubt on the absolute need for paclitaxel in first line.…”

Section: Discussionsupporting

confidence: 75%

Long-term survival in a randomized study of nonplatinum therapy versus platinum in advanced epithelial ovarian cancer

Nicoletto

Tumolo

Sorio

et al. 2007

International Journal of Gynecological Cancer

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The purpose of this study was to compare long-term survival in first-line chemotherapy with and without platinum in advanced-stage ovarian cancer. From July 1987 to November 1992, 161 untreated patients with FIGO stage III-IV epithelial ovarian cancer were randomized: 81 patients received no platinum and 80 received platinum combination. Residual disease after surgery was <2 cm in 61 patients without platinum, 59 with platinum. Median age was 58 years in nonplatinum arm and 55 years in platinum arm (range: 15-73). Complete and partial responses were 51% and 10% for nonplatinum arm and 51% and 8% for platinum arm, respectively (P= 0.7960). Stable disease was observed in 18% of patients in nonplatinum arm and 15% of patients in platinum arm and progression in 20% of nonplatinum- and 21% of platinum-treated cases. Ten-year disease-free survival was 37% for therapy without platinum and 31% for platinum combination (P= 0.5679); 10-year overall survival was 23% without platinum and 31% with platinum combination (P= 0.2545). Fifteen-year overall survival showed a trend of short duration in favor of platinum (P= 0.0678). Relapses occurred after 60 months in ten patients (seven with and three without platinum). The overall and disease-free survivals at 5, 10, and 15 years show no statistically significant long-term advantage from the addition of cisplatin; however, there is a slight trend in its favor.

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Section: Discussionsupporting

confidence: 75%

Long-term survival in a randomized study of nonplatinum therapy versus platinum in advanced epithelial ovarian cancer

Nicoletto

Tumolo

Sorio

et al. 2007

International Journal of Gynecological Cancer

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“…This recommendation is based on level I evidence of two large randomized trials, which established that a combination of paclitaxel plus cisplatin was superior to cyclophosphamide plus cisplatin (26,27) . Mature data corroborate this superiority (28,29) and an analysis combining these two data sets demonstrates a survival advantage favoring cisplatin-paclitaxel, with a statistical significance rarely seen in cancer therapy trials (P ¼ 0.000001) (30) .…”

Section: Front-line Treatmentmentioning

confidence: 68%

“…The results of these studies, published with a median follow-up of about 3 years, have been updated with a 6.5-year follow-up time: in each case an 11% absolute gain in survival favoring the paclitaxel arm is shown; this advantage remains both statistically and clinically significant and supports a role for paclitaxel in frontline chemotherapy for advanced ovarian cancer (31) .…”

Section: Front-line Treatmentmentioning

confidence: 96%

Ovarian cancer treatment: what is new

Poveda

2003

Int J Gynecol Cancer

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Ovarian cancer is still the fourth cause of death by cancer among women and the most fatal among gynecological tumors. The purpose of this symposium is, year after year, to report and discuss the new developments in the treatment of patients with ovarian cancer, the majority of whom still present with advanced disease. It also tries to make it clear to the participants what is evidence-based and what is not. Mature data of both classic studies like GOG-111, OV-10, and more recent studies like GOG-158, AGO-OVAR-3, and the intergroup paclitaxel/epirubicin/carboplatin (TEC) versus paclitaxel/carboplatin (TC) study have been presented. Other current controversial issues included in this edition were sequential single-agent versus simultaneous administration of combination chemotherapy, the role of combination chemotherapy in second-line treatment, the role of consolidation therapy, the role of anthracyclines in the treatment, and cost-effectiviness studies in ovarian cancer. Although the main topic of the symposium is advanced disease, this edition included the results of two parallel randomized studies (ACTION and ICON1) on the treatment of early disease. In addition, new trends in early detection of ovarian cancer have been updated.The pace of new agent development has increased, and it would be helpful to have more efficient preclinical models and early phase-clinical trials to guide the selection of active agents for phase III evaluation. Reaching international consensus is a challenge but offers the opportunity to test multiple regimens more efficiently against a single-control population, rather than conducting multiple smaller studies with redundant internal controls. If indeed answers to the relevant questions are to be obtained more quickly, then, a network of current national or international groups could potentially facilitate this.

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“…As mentioned by Markman (13) , realistic goals of second-line treatment in ovarian cancer patients are (1) to improve cancer-related symptoms (2) , to optimize overall quality of life (3) , to delay time to symptomatic disease progression (4) , to prolong overall survival, and (5) to achieve an 'objective response'. Several agents have demonstrated activity in patients who have relapsed after platinum-based therapy.…”

Section: Second-line Treatmentmentioning

confidence: 99%

“…The fact that the vast majority of patients initially present with advanced-stage disease contributes to this high mortality rate. Nevertheless, improvements in cytoreductive surgery and the introduction of paclitaxel in the upfront platinum-based chemotherapy have increased progression-free and overall survival in recent years (2) . Despite high initial response rates, a large proportion of patients will relapse and ultimately die of their disease.…”

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confidence: 99%

The role of anthracyclines in second-line therapy of ovarian cancer

Vermorken¹

2003

Int J Gynecol Cancer

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Anthracyclines (ANTs) have been in clinical practice since the 1960s and represent one of the most commonly used classes of anticancer drugs. In the 1990s, meta-analyses showed a favorable impact of doxorubicin (DOX/A) on the survival of patients with advanced ovarian cancer, when it was combined with cyclophosphamide and cisplatin (CAP) and compared to CP alone. With the acceptance of paclitaxel-carboplatin (TCb) as the new reference arm for first-line treatment, testing the addition of ANTs to TCb seems a logic next step. Trials presently testing this, make use of either epirubicin (EPI) or pegylated liposomal doxorubicin (PLD: Doxil(R)/Caelyx(R)). These are the two most favorable ANTs, based on data obtained with various ANTs in ovarian cancer failing platinum-based chemotherapy. EPI has not been evaluated in direct comparison with other antineoplastic agents. PLD has been compared with both paclitaxel and topotecan. No difference in efficacy parameters could be observed, but the toxicity profile of PLD scored favorably against those of the comparator in both trials, despite the fact that palmar-plantar erythrodysesthesia can be troublesome, and sometimes lead to treatment discontinuation. Data from four randomized trials evaluating the role of ANT combinations in patients with relapsed ovarian cancer suggest that the addition of EPI or DOX to paclitaxel does not lead to better outcomes in patients with platinum- refractory or resistant disease. In platinum-sensitive disease, any benefit of EPI-platinum or DOX-platinum combinations over platinum alone is uncertain. There are no randomized trials with PLD combinations in the second-line setting. It is concluded that both EPI and PLD can be recommended as a reasonable single-agent treatment option for relapsed patients, with a preference for PLD taking into account its more favorable toxicity profile.

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Long-term follow-up confirms a survival advantage of the paclitaxel–cisplatin regimen over the cyclophosphamide–cisplatin combination in advanced ovarian cancer

Cited by 42 publications

References 6 publications

Long-term survival in a randomized study of nonplatinum therapy versus platinum in advanced epithelial ovarian cancer

Long-term survival in a randomized study of nonplatinum therapy versus platinum in advanced epithelial ovarian cancer

Ovarian cancer treatment: what is new

The role of anthracyclines in second-line therapy of ovarian cancer

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