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Long-term results from a phase II study of single agent paclitaxel (Taxol) in previously platinum treated patients with advanced ovarian cancer : the Nordic experience

Tropé, C ; Hogberg, T LU ; Kaern, J ; Bertelsen, K ; Bjorkholm, E ; Boman, K ; Himmelmann, A ; Horvath, G ; Jacobsen, A and Kuoppola, T , et al. (1998) In Annals of oncology : official journal of the European Society for Medical Oncology 9(12). p.1301-1307
Abstract

BACKGROUND: Owing to the wide spread perception of a possible benefit from paclitaxel in the second-line situation the Nordic Gynecologic Oncology Group (NGOG) conducted two prospective phase II studies of paclitaxel single agent treatment (175 mg/m2, three-hour i.v. infusion with standard pre-medication every third week) in patients with relapsing or progressing epithelial ovarian cancer following platinum.

PATIENTS AND METHODS: Between 1992-1994 138 patients in total were enrolled of whom 136 received paclitaxel and were included in the toxicity and survival analysis, while 112 were evaluable for response.

RESULTS: The overall response rate (CR + PR) was 28% with 16 patients achieving a CR (14%). The estimated median... (More)

BACKGROUND: Owing to the wide spread perception of a possible benefit from paclitaxel in the second-line situation the Nordic Gynecologic Oncology Group (NGOG) conducted two prospective phase II studies of paclitaxel single agent treatment (175 mg/m2, three-hour i.v. infusion with standard pre-medication every third week) in patients with relapsing or progressing epithelial ovarian cancer following platinum.

PATIENTS AND METHODS: Between 1992-1994 138 patients in total were enrolled of whom 136 received paclitaxel and were included in the toxicity and survival analysis, while 112 were evaluable for response.

RESULTS: The overall response rate (CR + PR) was 28% with 16 patients achieving a CR (14%). The estimated median (range) time to progression was 4.1 (0.7-60.7) months. The projected four-year overall survival was 7%, with a median (range) of 9.6 (0.3-60.7) months. A multivariate logistic regression analysis showed that platinum resistance, and WHO performance status at baseline, independently correlated with survival at all three time points (median survival time 9.6, 18, and 24 months). Patients with platinum sensitive tumors and WHO performance status 0 had a median survival of 25.6 months compared to 7.0 months for the rest of the patients (P < or = 0.0001). No serious toxicity was registered.

CONCLUSION: Paclitaxel could safely be administered in an outpatient setting using this schedule. Patients with platinum sensitive tumors and a good performance status were most likely to survive. However, these patients are also most likely to respond to re-treatment with a platinum compound. With reference to the reasonably good tumor control and limited toxicity observed in this study, we conclude that paclitaxel single agent therapy is a viable option in the salvage situation, which in some patients can give long-lasting responses. However, although responses can be induced in a significant number of patients, the survival figures remain poor.

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publishing date
type
Contribution to journal
publication status
published
keywords
Adult, Antineoplastic Agents, Phytogenic/adverse effects, Cisplatin/administration & dosage, Disease Progression, Disease-Free Survival, Drug Resistance, Neoplasm, Female, Humans, Norway/epidemiology, Ovarian Neoplasms/drug therapy, Paclitaxel/adverse effects, Remission Induction, Salvage Therapy, Survival Analysis, Survival Rate, Treatment Outcome
in
Annals of oncology : official journal of the European Society for Medical Oncology
volume
9
issue
12
pages
7 pages
publisher
Oxford University Press
external identifiers
  • pmid:9932160
ISSN
0923-7534
DOI
10.1023/a:1008400324892
language
English
LU publication?
no
id
26707ad0-7763-47a5-b268-85447a85cce6
date added to LUP
2019-09-20 08:01:55
date last changed
2020-12-19 04:03:08
@article{26707ad0-7763-47a5-b268-85447a85cce6,
  abstract     = {<p>BACKGROUND: Owing to the wide spread perception of a possible benefit from paclitaxel in the second-line situation the Nordic Gynecologic Oncology Group (NGOG) conducted two prospective phase II studies of paclitaxel single agent treatment (175 mg/m2, three-hour i.v. infusion with standard pre-medication every third week) in patients with relapsing or progressing epithelial ovarian cancer following platinum.</p><p>PATIENTS AND METHODS: Between 1992-1994 138 patients in total were enrolled of whom 136 received paclitaxel and were included in the toxicity and survival analysis, while 112 were evaluable for response.</p><p>RESULTS: The overall response rate (CR + PR) was 28% with 16 patients achieving a CR (14%). The estimated median (range) time to progression was 4.1 (0.7-60.7) months. The projected four-year overall survival was 7%, with a median (range) of 9.6 (0.3-60.7) months. A multivariate logistic regression analysis showed that platinum resistance, and WHO performance status at baseline, independently correlated with survival at all three time points (median survival time 9.6, 18, and 24 months). Patients with platinum sensitive tumors and WHO performance status 0 had a median survival of 25.6 months compared to 7.0 months for the rest of the patients (P &lt; or = 0.0001). No serious toxicity was registered.</p><p>CONCLUSION: Paclitaxel could safely be administered in an outpatient setting using this schedule. Patients with platinum sensitive tumors and a good performance status were most likely to survive. However, these patients are also most likely to respond to re-treatment with a platinum compound. With reference to the reasonably good tumor control and limited toxicity observed in this study, we conclude that paclitaxel single agent therapy is a viable option in the salvage situation, which in some patients can give long-lasting responses. However, although responses can be induced in a significant number of patients, the survival figures remain poor.</p>},
  author       = {Tropé, C and Hogberg, T and Kaern, J and Bertelsen, K and Bjorkholm, E and Boman, K and Himmelmann, A and Horvath, G and Jacobsen, A and Kuoppola, T and Vartianen, J and Lund, B and Onsrud, M and Puistola, U and Salmi, T and Scheistroen, M and Sandvei, R and Simonsen, E and Sorbe, B and Tholander, B and Westberg, R},
  issn         = {0923-7534},
  language     = {eng},
  number       = {12},
  pages        = {1301--1307},
  publisher    = {Oxford University Press},
  series       = {Annals of oncology : official journal of the European Society for Medical Oncology},
  title        = {Long-term results from a phase II study of single agent paclitaxel (Taxol) in previously platinum treated patients with advanced ovarian cancer : the Nordic experience},
  url          = {http://dx.doi.org/10.1023/a:1008400324892},
  doi          = {10.1023/a:1008400324892},
  volume       = {9},
  year         = {1998},
}