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A feasibility study of testing new drugs for small-cell lung cancer in patients with a poor performance status
P E Postmus1, E F Smit, H H Berendsen
1Department of Pulmonology, University Hospital Groningen, The Netherlands.
Abstract:
Testing of new drugs in small-cell lung cancer is definitely necessary for the development of agents that might be effective against this tumor. However, testing such drugs in previously untreated patients with a good performance status (PS) may give rise to ethical problems. When previously treated patients are used in testing, potentially effective agents could well elude discovery. Patients who are not eligible for "standard" combination chemotherapy, e.g. untreated patients with a poor PS, may be suitable for testing of new drugs. To evaluate the potential usefulness of such patients in the testing of new agents, we evaluated an effective drug (etoposide) at a relatively nontoxic dose in a group of 14 patients with a PS of 4 (WHO). Oral etoposide resulted in a response in only 3 cases, whereas 5 subjects died of therapy-related toxicity. We conclude that previously untreated patients with a poor PS are not suitable candidates for the testing of new drugs.
Insights
Testing new cancer drugs requires careful patient selection. Poor performance status patients are unsuitable for early drug trials, as demonstrated by high toxicity with etoposide in small-cell lung cancer.
Area of Science:
- Oncology
- Clinical Pharmacology
Background:
- Drug development for small-cell lung cancer (SCLC) is crucial.
- Testing novel agents in patients with good performance status (PS) raises ethical concerns.
- Previously treated patients may not accurately reflect a new drug's potential.
Purpose of the Study:
- To assess the suitability of patients with poor performance status (PS) for novel drug testing in SCLC.
- To evaluate the efficacy and toxicity of etoposide in a cohort of patients with PS 4 (WHO).
Main Methods:
- A study was conducted on 14 patients with small-cell lung cancer and a WHO performance status of 4.
- Patients received oral etoposide at a dose considered relatively non-toxic.
Main Results:
- Only 3 out of 14 patients showed a response to oral etoposide.
- A significant proportion of patients (5 out of 14) died due to therapy-related toxicity.
Conclusions:
- Untreated patients with poor performance status are not appropriate candidates for early-phase drug testing.
- The high toxicity observed suggests that this patient group may not tolerate investigational agents well.
- Alternative patient populations or trial designs may be necessary for evaluating new SCLC drugs.