ith limited or extensive small cell lung cancer and no prior therapy were treated with either cisplatin plus etoposide or cisplatin plus etoposide phosphate. Patients received 20 mg/m2/day of cisplatin for 5 days and 80 mg/m2/day of etoposide or etoposide phosphate. A total of 121 patients were randomized and 120 treated (60 per group). Response rates, time to response, duration of response, time to progression, time to worsening performance status, and survival were similar in the two groups whether the analysis was done for patients with limited or extensive disease or for the entire population. The following table summarizes the results regardless of disease extent.
Response to Treatment for All Patients Etoposide Phosphate
plus Cisplatin Etoposide
plus Cisplatin
P-value
*Fisher's Exact test
**Wilcoxon Rank Sum test
***Logrank test
Complete Responses: 15% 15% 1.000*
Partial Responses: 46% 43% 0.855*
Overall Response Rate: 61% 58% 0.854*
Median Time to Response: 48 days 46 days 0.596**
Median Response Duration: 273 days 241 days 0.141***
Median Time to Progression: 211 days 213 days 0.500***
Median Time to Worsening
Performance Status: 210 days 149 days 0.472***
Median Survival: 348 days 318 days 0.780***
Fisher's Exact test
**Wilcoxon Rank Sum test
***Logrank test
Complete Responses: 15% 15% 1.000*
Partial Responses: 46% 43% 0.855*
Overall Response Rate: 61% 58% 0.854*
Median Time to Response: 48 days 46 days 0.596**
Median Response Duration: 273 days 241 days 0.141***
Median Time to Progression: 211 days 213 days 0.500***
Median Time to Worsening
Performance Status: 210 days 149 days 0.472***
Median Survival: 348 days 318 days 0.780***
The most prominent side effects were myelosuppression and GI toxicity. Sixty-eight percent of patients treated with etoposide phosphate plus cisplatin had neutrophils less than 500/mm3 at some time during treatment as did 88% of those getting etoposide and cisplatin. Over 85% in each group had nausea and/or vomiting. No differences in the pattern or severity of side effects were observed.
Indications and Usage for Etopophos
Etopophos for Injection is indicated in the management of the following neoplasms:
Refractory Testicular Tumors-Etopophos for Injection in combination therapy with other approved chemotherapeutic agents in patients with refractory testicular tumors who have already received appropriate surgical, chemotherapeutic, and radiotherapeutic therapy.
Small Cell Lung Cancer-Etopophos for Injection in combination with other approved chemotherapeutic agents as first-line treatment in patients with small cell lung cancer.
Contraindications
Etopophos for Injection is contraindicated in patients who have demonstrated a previous hypersensitivity to etoposide, etoposide phosphate, or any other component of the formulations.
Warnings
Patients being treated with Etopophos must be frequently observed for myelosuppression both during and after therapy. Myelosuppression resulting in death has been reported following etoposide administration. Dose-limiting bone marrow suppression is the most significant toxicity associated with Etopophos therapy. Therefore, the following studies should be obtained at the start of therapy and prior to each subsequent cycle of Etopophos: platelet count, hemoglobin, white blood cell count, and |
