A three-week schedule of gemcitabine-cisplatin in advanced non-small-cell lung cancer with two different cisplatin dose levels: A phase II randomized trial

M. Rinaldi, L. Crinò, G. V. Scagliotti, A. M. Mosconi, F. De Marinis, C. Gridelli, G. Selvaggi, M. Della Giulia, S. Darwish, S. Porrozzi, S. Novello, A. Cipri, R. Bartolucci, C. Calandri, M. Tonato

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Abstract

Background: To explore a new schedule of gemcitabine-cisplatin (GP) combination therapy using two different cisplatin doses in patients with advanced non-small-cell lung cancer (NSCLC). Patients and methods: From May to December 1997, 92 chemonaive patients entered the study and 88 (28 with locally advanced and 60 with disseminated NSCLC) were evaluable for response and toxicity (45 in arm A and 43 in arm B). Patients were randomly assigned to arm A or arm B. Gemcitabine 1000 mg/m2 was given on days 1-8 plus cisplatin 100 mg/m2 in arm A and cisplatin 70 mg/m2 in arm B on day 2 of every 21-day cycle. Results: The overall response rates in arms A and B were 42% (95% confidence interval (CI): 27.8%-56.7%) and 47% (95% CI: 31.6%-61.5%), respectively. Median duration of response was 9.7 months (range 1.8 to 30.9 months; 13.1 and 9.5 months for arm A and B, respectively), and median survival was 12 months (range 0.2 to 31.1 months; 15.4 and 11.5 months for arm A and B, respectively). Major WHO grade 3-4 toxicities in arm A vs. arm B included: thrombocytopenia (23% vs. 17% of courses), leukopenia (15% vs. 4% of courses), anemia (7% vs. 6% of courses), and nausea-vomiting (20% vs. 7% of patients). Grade 1-2 nephrotoxicity occurred in 20% of patients in arm A and in 7% of patients in arm B, with one grade 4 episode in arm A. Six patients discontinued treatment because of toxicities, 5 in arm A and 1 in arm B. Conclusions: Results of this trial indicate that both schedules are feasible and active, with a milder toxicity in the arm with the lower cisplatin dose.

Original languageEnglish
Pages (from-to)1295-1300
Number of pages6
JournalAnnals of Oncology
Volume11
Issue number10
DOIs
Publication statusPublished - 2000

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gemcitabine
Non-Small Cell Lung Carcinoma
Cisplatin
Appointments and Schedules
Confidence Intervals
Leukopenia
Thrombocytopenia
Nausea
Vomiting
Anemia

Keywords

  • Advanced NSCLC
  • Cisplatin dose level
  • Gemcitabine-cisplatin combination

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

A three-week schedule of gemcitabine-cisplatin in advanced non-small-cell lung cancer with two different cisplatin dose levels : A phase II randomized trial. / Rinaldi, M.; Crinò, L.; Scagliotti, G. V.; Mosconi, A. M.; De Marinis, F.; Gridelli, C.; Selvaggi, G.; Della Giulia, M.; Darwish, S.; Porrozzi, S.; Novello, S.; Cipri, A.; Bartolucci, R.; Calandri, C.; Tonato, M.

In: Annals of Oncology, Vol. 11, No. 10, 2000, p. 1295-1300.

Research output: Contribution to journalArticle

Rinaldi, M, Crinò, L, Scagliotti, GV, Mosconi, AM, De Marinis, F, Gridelli, C, Selvaggi, G, Della Giulia, M, Darwish, S, Porrozzi, S, Novello, S, Cipri, A, Bartolucci, R, Calandri, C & Tonato, M 2000, 'A three-week schedule of gemcitabine-cisplatin in advanced non-small-cell lung cancer with two different cisplatin dose levels: A phase II randomized trial', Annals of Oncology, vol. 11, no. 10, pp. 1295-1300. https://doi.org/10.1023/A:1008334610955
Rinaldi, M. ; Crinò, L. ; Scagliotti, G. V. ; Mosconi, A. M. ; De Marinis, F. ; Gridelli, C. ; Selvaggi, G. ; Della Giulia, M. ; Darwish, S. ; Porrozzi, S. ; Novello, S. ; Cipri, A. ; Bartolucci, R. ; Calandri, C. ; Tonato, M. / A three-week schedule of gemcitabine-cisplatin in advanced non-small-cell lung cancer with two different cisplatin dose levels : A phase II randomized trial. In: Annals of Oncology. 2000 ; Vol. 11, No. 10. pp. 1295-1300.
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abstract = "Background: To explore a new schedule of gemcitabine-cisplatin (GP) combination therapy using two different cisplatin doses in patients with advanced non-small-cell lung cancer (NSCLC). Patients and methods: From May to December 1997, 92 chemonaive patients entered the study and 88 (28 with locally advanced and 60 with disseminated NSCLC) were evaluable for response and toxicity (45 in arm A and 43 in arm B). Patients were randomly assigned to arm A or arm B. Gemcitabine 1000 mg/m2 was given on days 1-8 plus cisplatin 100 mg/m2 in arm A and cisplatin 70 mg/m2 in arm B on day 2 of every 21-day cycle. Results: The overall response rates in arms A and B were 42{\%} (95{\%} confidence interval (CI): 27.8{\%}-56.7{\%}) and 47{\%} (95{\%} CI: 31.6{\%}-61.5{\%}), respectively. Median duration of response was 9.7 months (range 1.8 to 30.9 months; 13.1 and 9.5 months for arm A and B, respectively), and median survival was 12 months (range 0.2 to 31.1 months; 15.4 and 11.5 months for arm A and B, respectively). Major WHO grade 3-4 toxicities in arm A vs. arm B included: thrombocytopenia (23{\%} vs. 17{\%} of courses), leukopenia (15{\%} vs. 4{\%} of courses), anemia (7{\%} vs. 6{\%} of courses), and nausea-vomiting (20{\%} vs. 7{\%} of patients). Grade 1-2 nephrotoxicity occurred in 20{\%} of patients in arm A and in 7{\%} of patients in arm B, with one grade 4 episode in arm A. Six patients discontinued treatment because of toxicities, 5 in arm A and 1 in arm B. Conclusions: Results of this trial indicate that both schedules are feasible and active, with a milder toxicity in the arm with the lower cisplatin dose.",
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T1 - A three-week schedule of gemcitabine-cisplatin in advanced non-small-cell lung cancer with two different cisplatin dose levels

T2 - A phase II randomized trial

AU - Rinaldi, M.

AU - Crinò, L.

AU - Scagliotti, G. V.

AU - Mosconi, A. M.

AU - De Marinis, F.

AU - Gridelli, C.

AU - Selvaggi, G.

AU - Della Giulia, M.

AU - Darwish, S.

AU - Porrozzi, S.

AU - Novello, S.

AU - Cipri, A.

AU - Bartolucci, R.

AU - Calandri, C.

AU - Tonato, M.

PY - 2000

Y1 - 2000

N2 - Background: To explore a new schedule of gemcitabine-cisplatin (GP) combination therapy using two different cisplatin doses in patients with advanced non-small-cell lung cancer (NSCLC). Patients and methods: From May to December 1997, 92 chemonaive patients entered the study and 88 (28 with locally advanced and 60 with disseminated NSCLC) were evaluable for response and toxicity (45 in arm A and 43 in arm B). Patients were randomly assigned to arm A or arm B. Gemcitabine 1000 mg/m2 was given on days 1-8 plus cisplatin 100 mg/m2 in arm A and cisplatin 70 mg/m2 in arm B on day 2 of every 21-day cycle. Results: The overall response rates in arms A and B were 42% (95% confidence interval (CI): 27.8%-56.7%) and 47% (95% CI: 31.6%-61.5%), respectively. Median duration of response was 9.7 months (range 1.8 to 30.9 months; 13.1 and 9.5 months for arm A and B, respectively), and median survival was 12 months (range 0.2 to 31.1 months; 15.4 and 11.5 months for arm A and B, respectively). Major WHO grade 3-4 toxicities in arm A vs. arm B included: thrombocytopenia (23% vs. 17% of courses), leukopenia (15% vs. 4% of courses), anemia (7% vs. 6% of courses), and nausea-vomiting (20% vs. 7% of patients). Grade 1-2 nephrotoxicity occurred in 20% of patients in arm A and in 7% of patients in arm B, with one grade 4 episode in arm A. Six patients discontinued treatment because of toxicities, 5 in arm A and 1 in arm B. Conclusions: Results of this trial indicate that both schedules are feasible and active, with a milder toxicity in the arm with the lower cisplatin dose.

AB - Background: To explore a new schedule of gemcitabine-cisplatin (GP) combination therapy using two different cisplatin doses in patients with advanced non-small-cell lung cancer (NSCLC). Patients and methods: From May to December 1997, 92 chemonaive patients entered the study and 88 (28 with locally advanced and 60 with disseminated NSCLC) were evaluable for response and toxicity (45 in arm A and 43 in arm B). Patients were randomly assigned to arm A or arm B. Gemcitabine 1000 mg/m2 was given on days 1-8 plus cisplatin 100 mg/m2 in arm A and cisplatin 70 mg/m2 in arm B on day 2 of every 21-day cycle. Results: The overall response rates in arms A and B were 42% (95% confidence interval (CI): 27.8%-56.7%) and 47% (95% CI: 31.6%-61.5%), respectively. Median duration of response was 9.7 months (range 1.8 to 30.9 months; 13.1 and 9.5 months for arm A and B, respectively), and median survival was 12 months (range 0.2 to 31.1 months; 15.4 and 11.5 months for arm A and B, respectively). Major WHO grade 3-4 toxicities in arm A vs. arm B included: thrombocytopenia (23% vs. 17% of courses), leukopenia (15% vs. 4% of courses), anemia (7% vs. 6% of courses), and nausea-vomiting (20% vs. 7% of patients). Grade 1-2 nephrotoxicity occurred in 20% of patients in arm A and in 7% of patients in arm B, with one grade 4 episode in arm A. Six patients discontinued treatment because of toxicities, 5 in arm A and 1 in arm B. Conclusions: Results of this trial indicate that both schedules are feasible and active, with a milder toxicity in the arm with the lower cisplatin dose.

KW - Advanced NSCLC

KW - Cisplatin dose level

KW - Gemcitabine-cisplatin combination

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