Combination Chemotherapy In Elderly Patients Research Articles

A multicenter, open-label, phase II trial of pemetrexed plus bevacizumab in elderly patients with previously untreated advanced or recurrent nonsquamous non-small cell lung cancer.

Although the incidence of lung cancer in elderly individuals has been increasing in recent years, the number of clinical trials designed specifically for elderly patients with advanced non-small cell lung cancer (NSCLC) is still limited. To fulfill this unmet medical need, we conducted a phase II study to elucidate the efficacy of pemetrexed (PEM) plus bevacizumab (Bev) combination chemotherapy in elderly patients with nonsquamous NSCLC. A total of 29 elderly patients (≥75 years old) with nonsquamous NSCLC were enrolled in this multicenter, open-label, phase II study, and 27 patients were finally analyzed. PEM at 500 mg/m2 on day 1 plus Bev at 15 mg/kg on day 1 were administered triweekly. The primary endpoint was the investigator-assessed objective response rate. The median age at initiating chemotherapy was 80 years old. Almost all patients (92.6%) had adenocarcinoma histology. The median number of cycles administered was 6, and the objective response rate was 40.7%. The median progression-free survival, overall survival and 1-year survival were 8.8 months, 27.2 months and 79%, respectively. The treatment was well-tolerated, and no treatment-related death was observed. Combination chemotherapy with PEM plus Bev in elderly patients with previously untreated advanced non-squamous NSCLC exhibited favorable antitumor activity and tolerability, suggesting that a combination of PEM plus Bev might be a promising treatment option for this population.

Real-world data of atezolizumab plus carboplatin and etoposide in elderly patients with extensive-disease small-cell lung cancer.

The aim of this study was to assess the effectiveness and tolerability of atezolizumab plus carboplatin and etoposide combination chemotherapy in elderly patients with extensive-disease (ED) small-cell lung cancer (SCLC). This retrospective study evaluated 65 SCLC patients who received atezolizumab, carboplatin, and etoposide for ED-SCLC in nine study institutions between August 2019 and September 2020. Clinical efficacy, assessed according to response rate and survival, and toxicity were compared between the elderly (n=36 patients; median age: 74 years [range: 70-89 years]) and the non-elderly group (n=29 patients; median age: 67 years [range: 43-69 years]). The response rate was 73.8% (80.5% in the elderly group and 65.5% in the non-elderly group). There was no significant difference in both the median progression-free survival (5.5months vs. 4.9months, p=0.18) and the median overall survival (15.4months vs. 15.9months, p=0.24) between the elderly group and the non-elderly group. The frequencies of grade ≥3 hematological adverse events in the elderly patients were as follows: decreased white blood cells, 36.1%; decreased neutrophil count, 61.1%; decreased platelet count, 8.3%; and febrile neutropenia, 8.3%. One treatment-related death due to lung infection occurred in the elderly group. Despite hematologic toxicities, especially decreased neutrophil count, atezolizumab, carboplatin, and etoposide combination chemotherapy demonstrates favorable effectiveness and acceptable toxicity in elderly patients. Thus, atezolizumab plus carboplatin and etoposide could be the preferred standard treatment modality for elderly patients with ED-SCLC.

The clinical outcomes of combination chemotherapy in elderly patients with advanced biliary tract cancer: an exploratory analysis of JCOG1113

In the FUGA-BT trial (JCOG1113), gemcitabine plus S-1 (GS) showed non-inferiority to gemcitabine plus cisplatin (GC) in overall survival (OS) with good tolerance for patients with advanced biliary tract cancer (BTC). We performed a subgroup analysis focused on the elderly cohort of this trial. All 354 enrolled patients in JCOG1113 were classify into two groups; < 75 (non-elderly) and ≥ 75 years (elderly) group. We investigated the influence of age on the safety analysis, including the incidence of chemotherapeutic adverse events and the efficacy analysis, including OS. There were no remarkable differences in OS between the elderly (n = 60) and the non-elderly groups (n = 294). In the elderly group, median OS was 12.7 and 17.7 months for those who received GC (n = 20) and GS (n = 40), respectively. The prevalence of all-grade adverse events was similar between the elderly and the non-elderly groups. However, among the elderly group, Grade ≥ 3 hematological adverse events were more frequently observed in the GC arm than in the GS arm. The clinical outcomes of combination chemotherapy in elderly patients with advanced BTC were comparable to non-elderly patients. GS may be the more favorable treatment for elderly patients with advanced BTC.

Survival Benefit of Combination Chemotherapy in Elderly Patients With Metastatic Pancreatic Ductal Adenocarcinoma.

Survival benefit of combination over single-agent chemotherapy for metastatic pancreatic ductal adenocarcinoma (PDAC) was demonstrated in younger patients in clinical trials. The authors aimed to evaluate whether this survival benefit of combination chemotherapy is present in elderly patients with metastatic PDAC. The authors identified elderly patients (age 65 y or older) with stage IV PDAC and extracted available clinical information from a prospectively maintained institutional pancreatic cancer registry from 2007 to 2016. The primary endpoint was overall survival. Cox proportional hazards regression was used for multivariable survival analyses. Survival outcomes for the entire cohort and by age group I (elderly, 65 to 75 y) and age group II (very elderly, older than 75 y) were assessed. A total of 606 patients were included with a median age of 73.8 years. Among them, 239 patients (39%) received combination chemotherapy and 152 patients (25.1%) received single-agent chemotherapy as first-line treatment. Combination chemotherapy was associated with significantly longer median overall survival compared with single-agent chemotherapy (10.9 vs. 7.5 mo, P<0.001) with hazard ratio 0.62 (95% confidence interval, 0.47-0.81; P=0.001) after adjusting for age, sex, comorbidity, Eastern Cooperative Oncology Group (ECOG) performance status, and carbohydrate antigen 19-9 level. Analyses by age groups indicated that very elderly patients (age group II) benefited from combination chemotherapy compared with single-agent chemotherapy with hazard ratio 0.56 (95% confidence interval, 0.31-1; P=0.049), comparable with the age group I (Page-treatment interaction=0.81). Elderly patients, even those older than 75 years, with metastatic PDAC benefited from combination chemotherapy.

The role of neoadjuvant chemotherapy in elderly patients with borderline or locally advanced pancreatic cancer: Is it safe and feasible?

685 Background: For borderline resectable (BRPC) or locally advanced pancreatic cancer (LAPC), neoadjuvant (NAT) FOLFIRINOX or gemcitabine plus nab-paclitaxel (GnP) are standard treatment options and these regimens have shown a survival advantage over single-agent gemcitabine. However, the role of these modern therapeutic regimens in elderly patients is debatable. In this analysis, we evaluated the outcomes of neoadjuvant treatment (NAT) with combination chemotherapy in elderly patients. Methods: 230 consecutive patients who underwent neoadjuvant treatment for BRPC/LAPC discussed and planned for NAT at the University of Colorado Cancer Center from January 2011 to March 2019 were reviewed. 214 patients who received FOLFIRINOX (n = 143) or GnP (n = 71) were eligible for analysis. We divided all patients into three groups ( &lt; 70, 70-74, ≥75 years) and compared the short-term and long-term outcomes. Results: Of 214 patients, patients &lt; 70 (n = 147) received FOLFIRINOX more frequently than the other groups (p &lt; 0.001): FOLFIRINOX: 115 cases, GnP: 32 cases, 70-74 years (n = 33): FOLFIRINOX: 15 cases, GnP: 18 cases, and ≥75 years (n = 34): FOLFIRINOX: 13 cases, GnP: 21 cases. Resection rates were not statistically different between three groups ( &lt; 70: 62%, 70-74: 70%, ≥75 years: 56%, p = 0.504). There was a slight trend towards worse survival in the two older groups (Median Survival Time [MST]: &lt; 70: 23.2 mo., 70-74: 19.5 mo., ≥75 years: 17.6 mo., p = 0.075) The FOLFIRINOX group was superior to GnP group in all three groups (MST: &lt; 70: 25.6 vs 18.2 mo., p = 0.017; 70-74: 33.2 vs 16.1mo., p = 0.029; ≥75 years: not reached vs 16.1 mo., p = 0.135). There were no toxic deaths or 30 day mortality after pancreatectomy in the study population. Conclusions: Neoadjuvant combination chemotherapy regimens were safe and feasible for elderly patients. Neoadjuvant therapy with FOLFIRINOX was associated with a survival advantage vs GnP and is an good option for fit and elderly patients ≥75 years.

The clinical outcomes of combination chemotherapy in elderly patients with advanced biliary tract cancer: An exploratory subgroup analysis of JCOG1113.

349 Background: JCOG1113 is a randomized phase III trial to confirm the non-inferiority of gemcitabine plus S-1 (GS) to gemcitabine plus cisplatin (GC) for advanced biliary tract cancer (BTC) in overall survival (OS). In the final analysis, GS demonstrated non-inferiority to GC in OS and was considered as a new option of standard of care for advanced BTC. However, there are few reports on the efficacy and safety of combination chemotherapy in elderly patients with advanced BTC. Therefore, this study aimed to explore the clinical outcomes of combination chemotherapy in elderly patients with advanced BTC. Methods: Among all enrolled patients in JCOG1113, ≥ 75 years old patients were included in this exploratory subgroup analysis. Cox regression analysis was performed to investigate the influence of age at baseline on OS and PFS. Clinically relevant adverse events (AEs) were defined as any of grade 2 or more fatigue, appetite loss, nausea, vomiting, oral mucositis, and diarrhea, and were compared using Fisher’s exact test. Results: Among all enrolled patients, 155 patients in GC and 139 patients in GS were included in &lt; 75 years old cohort and 20 patients in GC and 40 patients in GS were included in ≥ 75 years old cohort.The HR of ≥ 75 years old cohort to &lt; 75 years old cohort for OS was 0.96 (95% CI 0.71–1.30) in all enrolled patients. The HR of ≥ 75 years old cohort to &lt; 75 years old cohort for OS was 1.26 (95% CI 0.77–2.04) in GC, and 0.84 (95% CI 0.56–1.24) in GS. The HR of ≥ 75 years old cohort to &lt; 75 years old cohort for PFS was 1.01 (95% CI 0.63–1.61) in GC, and 0.78 (95% CI 0.54–1.12) in GS. Clinically relevant AEs were 36.1% in &lt; 75 years old cohort and 25.0% in ≥ 75 years old cohort in GC, and 29.5% in &lt; 75 years old cohort and 32.5% in ≥ 75 years old cohort in GS. Conclusions: The clinical outcomes of combination chemotherapy in elderly patients were comparable to non-elderly patients. Clinical trial information: 000010667.

Carboplatin-based combination chemotherapy for elderly patients with advanced bladder cancer.

We evaluated retrospectively the feasibility and effectiveness of carboplatin-based combination chemotherapy in elderly patients with advanced bladder cancer. Forty-seven patients with advanced bladder cancer (33 men and 14 women) and treated at our hospital between August 2004 and December 2011 were enrolled. The average age was 77.1 years (range 70-86 years), the average creatinine clearance was 37.0 ml/min (range 14.5-113.0 ml/min), and the average follow-up period was 17.4 months (range 10-55 months). Twenty-nine patients (61.7 %) were unfit for cisplatin-based chemotherapy. There were 15 recurrent cases after radical surgery and 32 inoperable cases. In this study, the first-line therapy was gemcitabine and carboplatin (GCarbo), with two courses as a set. The second-line therapy was GCarbo and docetaxel (GCarboD) if there was an insufficient response to the first-line therapy. Of the 47 patients who underwent GCarbo therapy, the response rate was 38.3 % (complete response plus partial response), with 5 and 13 patients exhibiting a complete response and a partial response, respectively. The average response duration was 15.7 months (range 2-42 months). The response rate of the nine patients who received GCarboD was 11.1 %, and the overall median survival was 15.0 months. Adverse events occurred in 30 patients (63.8 %) who underwent GCarbo therapy. Bone marrow suppression was observed in 30 patients (61.7 %), and digestive symptoms were observed in three patients (9.0 %). Our study demonstrates that GCarbo is a safe and effective combination chemotherapy in elderly patients with advanced bladder cancer. However, the GCarboD regimen appears to have limited effectiveness for nonresponders to GCarbo therapy.

Chemotherapy (Gemcitabine plus Carboplatin versus Paclitaxel plus Carboplatin) in Elderly Patients with Non-Small Cell Lung Cancer

Background: This retrospective study was to evaluate the efficacy and toxicity of gemcitabine plus carboplatin (GC regimen) and paclitaxel plus carboplatin (PC regimen) combination chemotherapy in elderly patients with non-small cell lung cancer. Methods: Seventy-four patients (GC regimen, n = 44; PC regimen, n= 30) received gemcitabine at a dose of 1000 mg/m2 on days 1 and 8, and carboplatin with the target dose of area under the curve (AUC) of 4 on day 8 every 28 days and paclitaxel at a dose of 70 mg/m2 on days 1, 8 and 15, and carboplatin with the target dose of AUC of 5 on day 1 every 28 days. Patients were divided in two groups (younger one: n = 42, old; elderly one: n= 32, ≥70 years old). Results: A total of 222 cycles of the treatment wasadministered. Seventy-one patients (95.9%) completed the scheduled cycles. Two patients in the elderly group were discontinued (6.3%) due to hematological toxicity and melena in the GC regimen and to grade 4 pneumonia in the PC regimen. The dose was reduced in 8 patients (10.8%) due to grade 4 thrombocytopenia. Grade 3/4 neutropenia was not significantly observed in both groups (younger group: 24/42, 57.1%; elderly group: 19/32, 59.4%, p = 0.8471). The nonhematological toxicities were mild in both groups. However, in theelderly group, grade 3/4 thrombocytopenia was significantly observed in the GC group (GC: 5/17, 29.4%; PC: 0/15, 0.0%, p = 0.0222). There was no treatment-related death. Conclusion: These results demonstrate that the GC and PC combination chemotherapies are efficacious and feasible regimens for lung cancer therapy, especially, both regimens should be considered as one of the standard therapies for elderly patients during lung cancer therapy.

Efficacy and feasibility of gemcitabine and carboplatin as first-line chemotherapy in elderly patients with advanced non-small cell lung cancer

Background Although platinum-based chemotherapy is a standard first-line treatment in advanced non-small cell lung cancer (NSCLC), further research for the safety and efficacy of combination chemotherapy in elderly patients has been required. The purpose of this study was to evaluate the efficacy and safety of gemcitabine and carboplatin as first-line treatment in elderly patients with advanced NSCLC and to evaluate the prognostic factors. Methods Eligibility included: (1) age of 70 years or more, (2) histologically confirmed NSCLC, (3) chemotherapy-naïve, (4) advanced disease with stage IIIB or IV, (5) Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2, (6) adequate organ function. Patients received intravenous carboplatin (area under curve (AUC)=5) on day 1 and gemcitabine (1000 mg/m2) on days 1 and 8, every 3 weeks. Results The medical records of forty patients were reviewed retrospectively. Median age was 73.9 years (range, 70-84.6), and there were 27 men (67.5%). Thirty-seven patients (92.5%) had ECOG PS 0-1. Adenocarcinoma was found in 57.5%. Median cycles were administrated with 4.5 per person (range: 1-6). Best responses were partial response in 22 (55.0%) patients and stable disease (SD) in 13 (32.5%). The median progression free survival (PFS) and overall survival (OS) were 5.9 months (95% CI: 4.5-7.3 months) and 9.6 months (95% CI: 8.2-11.0 months), respectively. Grade 4 hematologic toxicities for neutropenia (7.5%), thrombocytopenia (7.5%) and anemia (5.0%) were observed. Histology was significant prognostic factor for PFS (P=0.024). Conclusion Gemcitabine and carboplatin combination chemotherapy is an effective and manageable treatment option in elderly advanced NSCLC patients with good performance status.

Cisplatin-based combination chemotherapy in elderly patients with metastatic urothelial cancer.

269 Background: Cisplatin-based combination chemotherapy is considered standard first-line treatment for patients with metastatic urothelial carcinoma. However, cisplatin-based chemotherapy is frequently avoided in elderly patients due to concerns regarding treatment-related toxicities. We analyzed the efficacy, and tolerability, of cisplatin-based chemotherapy in two age groups (&lt; 70 versus ≥ 70 years old). Methods: Individual patient data was pooled from eight phase II and III trials evaluating cisplatin-based first-line chemotherapy in patients with metastatic urothelial carcinoma. Toxicities, treatment delivery, response proportions, and survival outcomes were compared between patients &lt; 70 versus ≥ 70 years old. Results: Of the 543 patients included in the analysis, 162 patients (30%) were ≥ 70 years old. Patients ≥ 70 years old had a significantly lower baseline calculated creatinine clearance (57 vs. 73 ml/min, p&lt;0.0001). All other baseline characteristics, including PS and visceral metastases were well balanced between the two age groups. Patients ≥ 70 years received a median of 1 cycle less of chemotherapy compared with younger patients (median cycles 5 versus 6; p = 0.004). There was no significant difference in the proportions of patients experiencing Grade 3-4 renal failure, febrile neutropenia, or treatment-related death. Response rate among patients ≥ 70 years old was 50% compared to 52% for patients &lt; 70 years old (p=0.65). There was no significant difference in survival between the age groups (p=0.91). The median survival of the patients ≥ 70 years old was 12.1 months compared to 12.8 months for patients &lt; 70 years old. There was no significant difference in survival between age groups when controlling for baseline performance status and/or the presence of visceral metastases. Conclusions: Elderly patients, with adequate renal function and other baseline characteristics suitable for clinical trial enrollment, tolerate cisplatin-based chemotherapy similarly, and achieve comparable clinical outcomes, compared with their younger counterparts. Cisplatin-based therapy need not be withheld from such patients.

Cisplatin-based Chemotherapy in Elderly Patients with Non-small Cell Lung Cancer

The use of cisplatin-based combination chemotherapy in elderly patients with advanced non-small cell lung cancer (NSCLC) remains an issue of debate. We retrospectively reviewed the medical records of all patients ≥ 70 years with stage IIIB and stage IV NSCLC who received chemotherapy between 2000 and 2007 at our hospital. Data on demographic information, chemotherapy regimen and cycle, response, toxicity, and survival time were collected. Survival was analyzed by the Kaplan-Meier method and log-rank test. A total of 102 elderly patients with advanced NSCLC received chemotherapy with a combination of cisplatin plus either vinorelbine or gemcitabine (the cisplatin-based combination group), or single-agent vinorelbine or gemcitabine (the single-agent group). The response rate was 46% in the cisplatin-based combination group, and 25% in the single-agent group ( p = 0.03). The median survival was 11.1 months (95% confidence interval, CI, 9.24–12.96] in the cisplatin-based combination group, and 8.9 months (95% CI, 7.68–10.14) in the single-agent group ( p = 0.06), and 1-year survival rates were 38.6% and 22.4%, respectively. The median progression-free survival was 7.9 months (95% CI, 5.62–10.18) and 5.8 months (95% CI, 4.78–6.82), respectively ( p = 0.03). Grade 3–4 anemia and neutropenia were more frequent in the cisplatin-based combination group. Other toxicities were mild and generally well tolerated in the two groups. Elderly patients ≥ 70 years with advanced NSCLC can tolerate and benefit from cisplatin-based combination chemotherapy. Cisplatin-based chemotherapy may be considered as an option in the treatment of elderly patients with advanced NSCLC.

P2-304: Multi-institutional phase ii study of carboplatin/gemcitabine combination chemotherapy in elderly patients (Pts) with advanced non-small cell lung cancer (NSCLC)

P2-304: Multi-institutional phase ii study of carboplatin/gemcitabine combination chemotherapy in elderly patients (Pts) with advanced non-small cell lung cancer (NSCLC)

Multi-institutional phase II study of carboplatin-gemcitabine combination chemotherapy in elderly patients (pts) with advanced non-small cell lung cancer (NSCLC)

18179 Background: Because elderly pts may tolerate platinum-based combination chemotherapy poorly, single-agent chemotherapy is selected for the treatment regimen. However, retrospective subgroup analyses have consistently indicated that elderly pts indeed benefit from platinum-based combination chemotherapy as well as their younger counterparts. This phase II study evaluated the efficacy and safety of carboplatin-gemcitabine combination chemotherapy in elderly pts with advanced NSCLC. Methods: Fifty-four pts aged more than 70 years old (median, 77; range, 70–88) with previously untreated advanced NSCLC were enrolled on this trial. Additional criteria included the presence of measurable lesions, an Eastern Cooperative Oncology Group performance status of 0 or 1, and adequate organ function. Pts received carboplatin at an area under the curve of 4 mg/ml/min on the first day and gemcitabine at 1000 mg/m2 on the first and eighth day of consecutive 3 week periods. The primary endpoint was to determine the objective response rate of this platinum-doublet regimen. The RECIST criteria were used to measure response. Results: Enrolled pts included 15/39 with stage IIIB/IV diseases. Fifty-one out of enrolled pts were eligible for efficacy and safety analyses. The median number of treatment cycles was 4 (range, 1–7). Fifteen partial responses (response rate: 29%) were obtained. The median TTP was 118 days. Hematological toxicities of grade 3/4 included leukopenia (46%), neutropenia (72%) and thrombocytopenia (50%). Non-hematological toxicities of grade 3/4 included nausea (6%), appetite loss (7%), fatigue (7%) and infection (9%). Conclusions: The combination carboplatin-gemcitabine at these doses has shown activity with a favorable toxicity profile for fit elderly pts with advanced NSCLC. No significant financial relationships to disclose.

First-Line Treatment Strategies for Elderly Patients with Metastatic Colorectal Cancer

Colorectal cancer ranks third in incidence in both men and women after lung, breast and prostate cancer. The prevalence of colorectal cancer increases significantly with age, with 40% of patients in Europe being >75 years of age at the time of initial diagnosis. Furthermore, the number of elderly patients with colorectal cancer is expected to increase significantly over the next two decades. Treatment of advanced colorectal cancer has evolved dramatically over the last decade. Advances in surgery and chemotherapy are effective in prolonging time to disease progression and survival in patients with advanced colorectal cancer. For >40 years, fluorouracil has been the mainstay of chemotherapy for advanced colorectal cancer. Recently, however, newer cytotoxic chemotherapies and biological agents effective against colorectal cancer have been shown to improve overall survival in metastatic disease. Thus, a patient with metastatic colorectal cancer today has an expected median survival of 20 months compared with 10 months only a few years ago. There is evidence that elderly individuals derive as much survival benefit from standard chemotherapy approaches in metastatic colorectal cancer as younger patients. Unfortunately, most older patients who might benefit from chemotherapy are not offered this treatment, and the fraction who are not offered it increases with increasing age. Treatment decisions should not be made on the basis of age. Rather, they should be based on functional status, the presence of co-morbidities, and consideration of drug-specific toxicities that can be aggravated in older individuals because of decreased functional reserve. Although the elderly have been under-represented in clinical trials, studies also support the effectiveness of combination chemotherapy in elderly patients with advanced colorectal cancer. This article reviews current optimal first-line treatment strategies for elderly patients with metastatic colorectal cancer.

Phase II Study of Carboplatin–Paclitaxel Combination Chemotherapy in Elderly Patients with Advanced Non-small Cell Lung Cancer

More than 30% of cases of non-small cell lung cancer (NSCLC) arise in patients aged > or =70 years. The efficacy and safety of carboplatin-paclitaxel combination chemotherapy in elderly patients with advanced NSCLC were evaluated in a phase II trial. Twenty-five patients aged > or =70 years (median, 76; range, 70-83) with chemotherapy-naive advanced NSCLC were enrolled between January 2001 and July 2003. Additional criteria included the presence of measurable lesions, an Eastern Cooperative Oncology Group performance status of 0 or 1, and adequate organ function. Patients received carboplatin at an area under the curve of 5 mg/ml/min and paclitaxel at 180 mg/m(2) on the first day of consecutive 3 week periods. The patients included four with stage IIIB, 19 with stage IV and two with recurrent disease. The median number of treatment cycles was three (range, 1-4). One complete response and six partial responses, yielding an objective response rate of 28%, were obtained. The median survival time was 12.3 months and the 1-year survival rate was 52%. Hematological toxicities of grade 3 or 4 included leukopenia (40%), neutropenia (68%) and anemia (4%). Non-hematological toxicities of grade 3 included arthralgia-myalgia (16%) and neuropathy (12%). The objective response rate for patients aged > or =75 years (n = 15) was 26%, and no evidence of excessive toxicity in these patients was apparent compared with those aged <75 years. The combination carboplatin-paclitaxel at these doses is a feasible treatment option with a favorable toxicity profile for fit elderly patients with advanced NSCLC.

Chemotherapy options for the elderly patient with advanced non-small cell lung cancer.

Combination chemotherapy has been shown to improve overall survival compared with best supportive care in patients with advanced non-small cell lung cancer (NSCLC). The survival advantage is modest and was initially demonstrated with cisplatin-containing regimens in a large meta-analysis of randomized trials reported in 1995. Newer chemotherapy combinations have been shown to be better tolerated than older cisplatin-based combinations, and some trials have also shown greater efficacy and survival benefits with these newer combinations. Combination chemotherapy is, therefore, the currently accepted standard of care for patients with good performance statuses aged less than 70 years with advanced NSCLC. However, there are limited data from clinical trials to support the use of combination chemotherapy in elderly patients over 70 years of age with advanced NSCLC. Subgroup analyses of large randomized phase III trials suggest that elderly patients with good performance statuses do as well as younger patients treated with combination chemotherapy. There are few randomized trials reported that evaluate chemotherapy in patients aged greater than 70 years only. Based on data from trials performed by an Italian group, single-agent vinorelbine has been shown to have significant activity in elderly patients with advanced NSCLC and to be well tolerated by those patients with Eastern Cooperative Oncology Group performance statuses of two or less, with associated improvements in measures of global health.