Randomized Trial of Single Agent Paclitaxel Given Weekly Versus Every Three Weeks and with Peroral Versus Intravenous Steroid Premedication to Patients with Ovarian Cancer Previously Treated with Platinum (original) (raw)

Authors

• Per Rosenberg From the Departments of Gynecological Oncology, University Hospital, Linko ping, Sweden (P. Rosenberg), Sahlgrenska Hospital, Gothenburg, Sweden (H. Andersson), Norrlands University Hospital, UmeaE , Sweden (K. Boman), University Hospital, Lund, Sweden (M. Ridderheim), University Hospital, Oe rebro, Sweden (B. Sorbe), University Hospital, Oulu, Finland (U. Puistola), and the Medical Oncology Department, BristolMyers Squibb, Stockholm, Sweden (G.Paro)
• Ha˚kan Andersson
• Karin Boman
• Mona Ridderheim
• Bengt Sorbe
• Ulla Puistola
• Gunnar Parö

DOI:

https://doi.org/10.1080/028418602320404998

Abstract

The aim of this study was to evaluate the efficacy and toxicity of paclitaxel given at the same dose intensity and administered weekly (arm A) or every 3 weeks (arm B), and to assess the safety of intravenous steroids versus standard peroral premedication. Two hundred and eight patients with advanced ovarian cancer previously treated with no more than one platinum-containing regimen were randomized to receive either a weekly infusion of paclitaxel or an infusion every 3 weeks. The median delivered dose intensity was 77.6 mg/m 2 /week in the weekly arm, and 72.7 mg/m 2 /week in the every 3 weeks arm. WHO grade 3-4 hematological and non-hematological toxicity occurred more frequently in arm B. No difference in number of severe events of hypersensitivity, response rate, time to progression or survival between arms was observed. Weekly paclitaxel at a dose of 67 mg/m 2 /week was found to have a better safety profile and seemed to be as effective as the equivalently dosed schedule every 3 weeks. Intravenous steroids are a safe alternative to oral steroids.

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Author Biographies

Ha˚kan Andersson

From the Departments of Gynecological Oncology, University Hospital, Linko ping, Sweden (P. Rosenberg), Sahlgrenska Hospital, Gothenburg, Sweden (H. Andersson), Norrlands University Hospital, UmeaE , Sweden (K. Boman), University Hospital, Lund, Sweden (M. Ridderheim), University Hospital, Oe rebro, Sweden (B. Sorbe), University Hospital, Oulu, Finland (U. Puistola), and the Medical Oncology Department, BristolMyers Squibb, Stockholm, Sweden (G.Paro)

Karin Boman

From the Departments of Gynecological Oncology, University Hospital, Linko ping, Sweden (P. Rosenberg), Sahlgrenska Hospital, Gothenburg, Sweden (H. Andersson), Norrlands University Hospital, UmeaE , Sweden (K. Boman), University Hospital, Lund, Sweden (M. Ridderheim), University Hospital, Oe rebro, Sweden (B. Sorbe), University Hospital, Oulu, Finland (U. Puistola), and the Medical Oncology Department, BristolMyers Squibb, Stockholm, Sweden (G.Paro)

Mona Ridderheim

From the Departments of Gynecological Oncology, University Hospital, Linko ping, Sweden (P. Rosenberg), Sahlgrenska Hospital, Gothenburg, Sweden (H. Andersson), Norrlands University Hospital, UmeaE , Sweden (K. Boman), University Hospital, Lund, Sweden (M. Ridderheim), University Hospital, Oe rebro, Sweden (B. Sorbe), University Hospital, Oulu, Finland (U. Puistola), and the Medical Oncology Department, BristolMyers Squibb, Stockholm, Sweden (G.Paro)

Bengt Sorbe

From the Departments of Gynecological Oncology, University Hospital, Linko ping, Sweden (P. Rosenberg), Sahlgrenska Hospital, Gothenburg, Sweden (H. Andersson), Norrlands University Hospital, UmeaE , Sweden (K. Boman), University Hospital, Lund, Sweden (M. Ridderheim), University Hospital, Oe rebro, Sweden (B. Sorbe), University Hospital, Oulu, Finland (U. Puistola), and the Medical Oncology Department, BristolMyers Squibb, Stockholm, Sweden (G.Paro)

Ulla Puistola

From the Departments of Gynecological Oncology, University Hospital, Linko ping, Sweden (P. Rosenberg), Sahlgrenska Hospital, Gothenburg, Sweden (H. Andersson), Norrlands University Hospital, UmeaE , Sweden (K. Boman), University Hospital, Lund, Sweden (M. Ridderheim), University Hospital, Oe rebro, Sweden (B. Sorbe), University Hospital, Oulu, Finland (U. Puistola), and the Medical Oncology Department, BristolMyers Squibb, Stockholm, Sweden (G.Paro)

Gunnar Parö

From the Departments of Gynecological Oncology, University Hospital, Linko ping, Sweden (P. Rosenberg), Sahlgrenska Hospital, Gothenburg, Sweden (H. Andersson), Norrlands University Hospital, UmeaE , Sweden (K. Boman), University Hospital, Lund, Sweden (M. Ridderheim), University Hospital, Oe rebro, Sweden (B. Sorbe), University Hospital, Oulu, Finland (U. Puistola), and the Medical Oncology Department, BristolMyers Squibb, Stockholm, Sweden (G.Paro)