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Front-line paclitaxel and irinotecan combination chemotherapy in advanced non-small-cell lung cancer: a phase I-II trial.

Stathopoulos GP, Dimitroulis J, Antoniou D, Katis C, Tsavdaridis D, Armenaki O, Marosis C, Michalopoulou P, Grigoratou T, Stathopoulos J - Br. J. Cancer (2005)

Bottom Line: Out of 46 evaluable patients, 19 achieved partial response (41.3%), 17 had stable disease (37%) and 10 (21.7%) experienced disease progression.The median duration of response was 6 months (range 2-9+ months).The main adverse reactions were myelotoxicity (grades 3 and 4) in 10 (19.2%) patients and diarrhoea (grade 3) in four (7.7%) patients.

View Article: PubMed Central - PubMed

Affiliation: First Oncology Deptartment, Errikos Dunant Hospital, Athens, Greece. dr-gps@ath.forthnet.gr

ABSTRACT
Our purpose was to determine the efficacy of irinotecan plus paclitaxel administered on day 1, repeated every 2 weeks, in untreated patients with advanced or metastatic non-small-cell lung cancer (NSCLC). In total, 56 patients with inoperable or metastatic stage III and IV NSCLC with a histologically or cytologically confirmed diagnosis were enrolled. None of the patients had undergone prior chemotherapy or radiation therapy. Treatment involved irinotecan 125 mg m(-2) and paclitaxel 135 mg m(-2) administered on day 1 and repeated every 2 weeks for a planned number of nine cycles. With a standard dose of paclitaxel at 135 mg m(-2), the dosage of irinotecan was escalated at four levels: 75, 100, 125 and 150 mg m(-2); 125 mg m(-2) was established as the maximum tolerated dose; this dosage was administered to 46 patients. A total of 52 patients (median age 65 years, range 38-77 years) were assessable for toxicity and survival and 46 for response rate. Out of 46 evaluable patients, 19 achieved partial response (41.3%), 17 had stable disease (37%) and 10 (21.7%) experienced disease progression. The median duration of response was 6 months (range 2-9+ months). The main adverse reactions were myelotoxicity (grades 3 and 4) in 10 (19.2%) patients and diarrhoea (grade 3) in four (7.7%) patients. Irinotecan combined with paclitaxel, administered every 2 weeks, appears to be an effective treatment for advanced-stage NSCLC.

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Related in: MedlinePlus

Survival distribution estimation (Kaplan–Meier method).
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fig1: Survival distribution estimation (Kaplan–Meier method).

Mentions: In total, 318 chemotherapy cycles were administered with a median of 6.63 cycles (range 2–9) per patient. The median interval between cycles was 15 days (range 15–22 days). Expected dose intensity for paclitaxel was 67.5 mg m−2 week−1 (mean dose intensity 66.2 mg m−2 week−1); the 95% CI was 65.1–67.2 mg m−2 week−1 (median dose intensity 67.5 mg m−2 week−1, range 54–67.5 mg m−2 week−1). The expected dose intensity for irinotecan was 60 mg m−2 week−1 (mean dose intensity 59 mg m−2 week−1); the 95% CI was 58.3–59.8 mg m−2 week−1 (median 60 mg m−2 week−1, range 50–60 mg m−2 week−1). In four patients, four cycles (once per patient) were delayed by 1 week. Three out of six patients at level four presented with grade 4 neutropenia and four out of six had grade 2 or 3 diarrhoea. In patients at dosage levels 1 and 2, grade 1 neutropenia and grade 1 or 2 diarrhoea were observed in two out of six patients. Of the 46 patients included in the phase II study (at dosage level 3), in two the dosage of both cytotoxic agents was reduced by 25% (after the third cycle in one, and after the fourth in the other). Treatment delay or dose reduction was due to grade 3 or 4 neutropenia in five cases and to hepatotoxicity (transaminasemia reversible) in one case. At the time of this analysis, 25 patients were still alive (48.1%) with a median follow-up time of 10 months (range 5–16 months). The Kaplan–Meier method was used for survival distribution estimation (Figure 1).


Front-line paclitaxel and irinotecan combination chemotherapy in advanced non-small-cell lung cancer: a phase I-II trial.

Stathopoulos GP, Dimitroulis J, Antoniou D, Katis C, Tsavdaridis D, Armenaki O, Marosis C, Michalopoulou P, Grigoratou T, Stathopoulos J - Br. J. Cancer (2005)

Survival distribution estimation (Kaplan–Meier method).
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC2361499&req=5

fig1: Survival distribution estimation (Kaplan–Meier method).
Mentions: In total, 318 chemotherapy cycles were administered with a median of 6.63 cycles (range 2–9) per patient. The median interval between cycles was 15 days (range 15–22 days). Expected dose intensity for paclitaxel was 67.5 mg m−2 week−1 (mean dose intensity 66.2 mg m−2 week−1); the 95% CI was 65.1–67.2 mg m−2 week−1 (median dose intensity 67.5 mg m−2 week−1, range 54–67.5 mg m−2 week−1). The expected dose intensity for irinotecan was 60 mg m−2 week−1 (mean dose intensity 59 mg m−2 week−1); the 95% CI was 58.3–59.8 mg m−2 week−1 (median 60 mg m−2 week−1, range 50–60 mg m−2 week−1). In four patients, four cycles (once per patient) were delayed by 1 week. Three out of six patients at level four presented with grade 4 neutropenia and four out of six had grade 2 or 3 diarrhoea. In patients at dosage levels 1 and 2, grade 1 neutropenia and grade 1 or 2 diarrhoea were observed in two out of six patients. Of the 46 patients included in the phase II study (at dosage level 3), in two the dosage of both cytotoxic agents was reduced by 25% (after the third cycle in one, and after the fourth in the other). Treatment delay or dose reduction was due to grade 3 or 4 neutropenia in five cases and to hepatotoxicity (transaminasemia reversible) in one case. At the time of this analysis, 25 patients were still alive (48.1%) with a median follow-up time of 10 months (range 5–16 months). The Kaplan–Meier method was used for survival distribution estimation (Figure 1).

Bottom Line: Out of 46 evaluable patients, 19 achieved partial response (41.3%), 17 had stable disease (37%) and 10 (21.7%) experienced disease progression.The median duration of response was 6 months (range 2-9+ months).The main adverse reactions were myelotoxicity (grades 3 and 4) in 10 (19.2%) patients and diarrhoea (grade 3) in four (7.7%) patients.

View Article: PubMed Central - PubMed

Affiliation: First Oncology Deptartment, Errikos Dunant Hospital, Athens, Greece. dr-gps@ath.forthnet.gr

ABSTRACT
Our purpose was to determine the efficacy of irinotecan plus paclitaxel administered on day 1, repeated every 2 weeks, in untreated patients with advanced or metastatic non-small-cell lung cancer (NSCLC). In total, 56 patients with inoperable or metastatic stage III and IV NSCLC with a histologically or cytologically confirmed diagnosis were enrolled. None of the patients had undergone prior chemotherapy or radiation therapy. Treatment involved irinotecan 125 mg m(-2) and paclitaxel 135 mg m(-2) administered on day 1 and repeated every 2 weeks for a planned number of nine cycles. With a standard dose of paclitaxel at 135 mg m(-2), the dosage of irinotecan was escalated at four levels: 75, 100, 125 and 150 mg m(-2); 125 mg m(-2) was established as the maximum tolerated dose; this dosage was administered to 46 patients. A total of 52 patients (median age 65 years, range 38-77 years) were assessable for toxicity and survival and 46 for response rate. Out of 46 evaluable patients, 19 achieved partial response (41.3%), 17 had stable disease (37%) and 10 (21.7%) experienced disease progression. The median duration of response was 6 months (range 2-9+ months). The main adverse reactions were myelotoxicity (grades 3 and 4) in 10 (19.2%) patients and diarrhoea (grade 3) in four (7.7%) patients. Irinotecan combined with paclitaxel, administered every 2 weeks, appears to be an effective treatment for advanced-stage NSCLC.

Show MeSH
Related in: MedlinePlus