Chemotherapy for Elderly Patients With Advanced Non-Small-Cell Lung Cancer: The Multicenter Italian Lung Cancer in the Elderly Study (MILES) Phase III Randomized Trial

Gridelli, Cesare; Perrone, Francesco; Gallo, Ciro; Cigolari, S.; Rossi, Antonio; Piantedosi, Francovito; Barbera, Santi; Ferraú, Francesco; Piazza, E.; Rosetti, Francesco; Clerici, M.; Bertetto, Oscar; Robbiati, Sergio; Frontini, L.; Sacco, Cosimo; Castiglione, F.; Favaretto, Adolfo; Novello, Silvia; Migliorino, Maria Rita; Gasparini, Giampietro; Galetta, Domenico; Iaffaioli, Rosario Vincenzo; Gebbia, Vittorio

doi:10.1093/jnci/95.5.362

Cited by 754 publications

(519 citation statements)

References 32 publications

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“…In contrast to the present study, the Multicenter Italian Lung cancer in Elderly Study (MILES) showed no survival benefit from gemcitabine plus vinorelbine (MTS, 30 weeks) vs either single agent (MST, 28 and 36 weeks, respectively) (Gridelli et al, 2003). However, 20% of patients entered in the MILES trial were affected by three, and 25% of patients by four or more associated diseases.…”

Section: Discussioncontrasting

confidence: 93%

“…The enrolment started in May 1999, and we anticipated to complete the case accrual in about 4 years. However, in March 2003 we decided to close the recruitment, in consideration of the slower than anticipated accrual, and on the basis of some ethical concern raised by a recently published trial in elderly patients, in which no survival benefit derived for the combination of gemcitabine plus vinorelbine over gemcitabine alone (Gridelli et al, 2003). Participating investigators were required to perform an ad hoc analysis of survival for patients enrolled until that date, allowing for a 6-month minimum follow-up after the last patient had been recruited.…”

Section: Statistical Analysis and Sample Sizementioning

confidence: 99%

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Gemcitabine with either paclitaxel or vinorelbine vs paclitaxel or gemcitabine alone for elderly or unfit advanced non-small-cell lung cancer patients

Comella

Frasci

Carnicelli³

et al. 2004

Br J Cancer

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The aim of this study was to assess whether a combination of gemcitabine (GEM) with either paclitaxel (PTX) or vinorelbine (VNR) could be more effective than GEM or PTX alone in elderly or unfit advanced non-small-cell lung cancer (NSCLC) patients. A total of 264 NSCLC patients aged 470 years with ECOG performance status (PS)p2, or younger with PS ¼ 2, were randomly treated with: GEM 1200 mg m À2 on days 1, 8 and 15 every 28 days; PTX 100 mg m À2 on days 1, 8 and 15 every 28 days; GEM 1000 mg m À2 plus PTX 80 mg m À2 (GT) on days 1 and 8 every 21 days; GEM 1000 mg m À2 plus VNR 25 mg m À2 (GV) on days 1 and 8 every 21 days. In all arms, an intra-patients dose escalation was applied over the first three courses, provided that no toxicity of WHO grade X2 had previously occurred. At present time, 217 (82%) patients had died. The median (months) and 1-year survival probability were 5.1 and 29% for GEM, 6.4 and 25% for PTX, 9.2 and 44% for GT, and 9.7 and 32% for GV. Multivariate analysis showed that PSp1 (hazard ratio (HR) ¼ 0.67; 95% CI 0.51 -0.90), and doublet treatments (HR ¼ 0.76; 95% CI 0.59 -0.99) were significantly associated with longer survival. Doublets produced no more toxicity than single agents. GT should be considered a reference regimen for elderly NSCLC patients with PSp1.

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Section: Discussioncontrasting

confidence: 93%

Section: Statistical Analysis and Sample Sizementioning

confidence: 99%

Gemcitabine with either paclitaxel or vinorelbine vs paclitaxel or gemcitabine alone for elderly or unfit advanced non-small-cell lung cancer patients

Comella

Frasci

Carnicelli³

et al. 2004

Br J Cancer

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“…Therefore, a single agent such as vinorelbine, whose effect on prolonging survival in advanced NSCLC with elderly has been demonstrated in comparison to the best supportive care (Anonymous, 1999), is sometimes selected to treat such patients in practice. In addition, the combination of vinorelbine plus gemcitabine has been reported to be not more effective than single-agent vinorelbine or gemcitabine in the treatment of elderly patients with advanced NSCLC (Gridelli et al, 2003).…”

Section: Discussionmentioning

confidence: 99%

UFT plus gemcitabine combination chemotherapy in patients with advanced non-small-cell lung cancer: a multi-institutional phase II trial

et al. 2005

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A multi-institutional phase II trial was conducted to evaluate the efficacy and toxicity of combination chemotherapy consisting of gemcitabine and UFT, which is composed of tegafur and uracil, for non-small-cell lung cancer (NSCLC) patients. Patients with advanced NSCLC received an oral administration of UFT (tegafur 200 mg m À2 ) b.i.d. from days 1 to 14 and intravenous injection of gemcitabine 900 mg m À2 on days 8 and 15. This treatment was repeated every 4 weeks. A total of 44 patients were enrolled into this trial. The median age of all patients was 74 years, with 23 patients younger than 75 years and 21 patients with 75 years of age or older. A total of 18 patients (41%) achieved a partial response. The median survival time was 13.2 months and the 1-year survival rate was 59%. The most common grade 3 -4 toxicity was neutropenia (57%). The frequency of grade 3 nonhaematologic toxicities was less than 5%. In addition, no significant difference in the response, survival or toxicities was observed between the patients younger than and those older than 75 years of age. This combination chemotherapy demonstrated a promising effectiveness and acceptable toxicity in patients with advanced NSCLC, even in patients older than 75 years.

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“…6,7,11 Recently, two randomized Phase III trials evaluated the efficacy of was terminated early (JCOG0803/WJOG4307L). 13 In this trial, the combination regimen was again more toxic.…”

Section: Discussionmentioning

confidence: 99%

“…6 Since then, vinorelbine monotherapy has become one of the most important chemotherapy regimens for elderly patients. 5,7 Carboplatin is a platinum derivative with less renal toxicity and causes less nausea and vomiting than cisplatin. 8 We therefore considered that vinorelbine and carboplatin could be an effective combination for elderly patients with previously untreated NSCLC and planned Phase I and II trials of this combination regimen.…”

Section: Introductionmentioning

confidence: 99%

Phase I and II Trials of Vinorelbine With Carboplatin for Patients 75 Years of Age or Older With Previously Untreated Non–Small-Cell Lung Cancer

Takatani

Nakamura

Nagashima

et al. 2012

Clinical Lung Cancer

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Chemotherapy for Elderly Patients With Advanced Non-Small-Cell Lung Cancer: The Multicenter Italian Lung Cancer in the Elderly Study (MILES) Phase III Randomized Trial

Abstract: The combination of vinorelbine plus gemcitabine is not more effective than single-agent vinorelbine or gemcitabine in the treatment of elderly patients with advanced NSCLC.

Cited by 754 publications

References 32 publications

Gemcitabine with either paclitaxel or vinorelbine vs paclitaxel or gemcitabine alone for elderly or unfit advanced non-small-cell lung cancer patients

Gemcitabine with either paclitaxel or vinorelbine vs paclitaxel or gemcitabine alone for elderly or unfit advanced non-small-cell lung cancer patients

UFT plus gemcitabine combination chemotherapy in patients with advanced non-small-cell lung cancer: a multi-institutional phase II trial

Phase I and II Trials of Vinorelbine With Carboplatin for Patients 75 Years of Age or Older With Previously Untreated Non–Small-Cell Lung Cancer

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