Treatment of Elderly Non-Small Lung Cancer (NSCLC) Patients with 3 Different Schedules of Weekly Paclitaxel in Combination with Carboplatin: Subanalysis of a Randomized Trial

Reviewer: Tracy d'Entremont, MD
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Ultima Vez Modificado: 31 de mayo del 2003

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Presenter: S. Ramalingam
Presenter's Affiliation: University of Pittsburgh Cancer Institute
Type of Session: Poster

Background

  • Benefit from combination chemotherapy extends to all age patients with advanced NSCLC
  • Elderly patients with good performance status have comparable efficacy with 'standard' platinum-based doublets.
  • There is concern of increased toxicity in some less fit elderly patients which may limit the administration of platinum-based combination chemotherapy.
  • Administration of weekly regimens appears to be better tolerated.

Materials and Methods

  • This is a subgroup analysis of a previously presented trial.
  • The trial was a randomized Phase II study of 3 different weekly schedules of carboplatin nad paclitaxel for patients with advanced NSCLC
  • This subanalysis compared the outcome of patients >/= 70 years with those <70 years.
  • The patients all had stage IIIB or IV NSCLC
  • They had no prior chemotherapy treatments.
  • All patients had to have ECOG PS of 0-2
  • The first schedule gave Carboplatin at AUC=6 once on D1 and Paclitaxel 100 mg/m2 on D1,8,15 of a q4 week schedule.
  • The second schedule gave Carboplatin AUC=2 on D1,8,15 and Paclitaxel 100 mg/m2 D1,8,15 on a q4 week schedule.
  • The third schedule gave Carboplatin AUC=2 q week and Paclitaxel 150 mg/m2/week for cycle 1 followed by paclitaxel 100 mg/m2/week for cycle 2. Each cycle consisted of 6 weeks of treatment followed by a 2 week break.
  • Upon completion of 16 weeks of therapy, patients who experienced a complete or partial response were again randomized to receive maintenance therapy with weekly paclitaxel at a dose of 70 mg/m2/wk for 3 out of 4 weeks or observation.

Results

  • Of the total 403 patients enrolled in this study, 111(28%) were aged 70 or above. 390 patients received at least one cycle of chemotherapy.
  • The arms were generally well balanced in terms of median age, male/female ratio, stage IIIb/IV, and ECOG PS=2 with one exception. The elderly patients in arm 2 were more likely to have an ECOG PS=2 and were more likely to be male compared with the other subgroups.
  • In the original study, the overall survival for all patients enrolled was higher in treatment arm 1, (monthly Carboplatin with weekly paclitaxel), with a median survival of 48 weeks.
  • When we look at the patients aged 70 and above, in this subgroup analysis, the survival is actually better in arm 3 with a median survival of 63 weeks, a 1-yr survival of 52%, and a 2-yr survival of 38%.
  • Overall patients aged 70 and above slightly higher rates of Gr 4 neutropenia and Febrile neutropenia in all three arms but less Gr 4 thrombocytopenia and less Gr 3 vomiting.

Author's Conclusions

    The author's conclude that:
  • This analysis demonstrates that pateints aged 70 and above have comparable efficacy in each of these three weekly schedules of carboplatin and paclitaxel when compared with patients less than 70 years of age.
  • There was no evidence of excessive toxicity in patients aged 70 and above when compared with the patients less than 70.
  • Arm 3 had the best therapeutic index overall

Clinical/Scientific Implications

    This study is another one proving that age alone should not be a factor when deciding whether to treat patients with advanced cancers with cytotoxic chemotherapy. It is often suggested by physicians who do not regularly treat cancer patients that age alone impacts toxicity and outcome from chemotherapy. This is another study to prove that this is not the case. Each patient should be evaluated on an individual basis and treatment should be offered based on performance status and co-morbidities not age.

Oncolink's ASCO Coverage made possible by an unrestricted Educational Grant from Bristol-Myers Squibb Oncology.


News
Doublet Chemo Improves Survival in Elderly With NSCLC

Aug 10, 2011 - Despite more toxic effects, doublet chemotherapy with carboplatin and weekly paclitaxel is associated with significantly higher survival benefits than monotheraphy with either vinorelbine or gemcitabine in elderly patients with advanced non-small-cell lung cancer, according to a study published online Aug. 9 in The Lancet.



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