Elderly Advanced Non-small Cell Lung Cancer Patients Research Articles

Clinical observation of nanoparticle albumin-bound paclitaxel monotherapy in the three-line treatment of elderly patients with advanced non-small cell lung cancer

Objective To evaluate the clinical efficacy and safety of nanoparticle albumin-bound paclitaxel (Nab-P) in the treatment of advanced non-small cell lung cancer (NSCLC). Methods Fifty-six over 65 years old patients with advanced NSCLC treated with Nab-P monotherapy in department of chemotherapy of the People's Hospital of Zhongshan City from January 2014 to January 2017 were analyzed retrospectively. The chemotherapy regimen was Nab-P 260 mg/m2, on d1 or d1 + d8, every 21 day for a cycle, imaging examination was made for efficacy evaluation after every 2 cycles. Results All 56 patients had been evaluated for efficacy, and received a total of 186 cycles of chemotherapy. All patients had been completed 2 cycles or more than 2 cycles of chemotherapy, and the median number of chemotherapy cycles was 3. The treatment response rate (RR) was 25.0% and the disease control rate (DCR) was 76.8%. The median progression free survival (PFS) time was 4.7 months. The main adverse reactions were neutropenia, nausea and vomiting, fatigue and peripheral nerve toxicity. However, the vast majorities of adverse reactions were grade 1-2, and can be improved after treatment. Conclusions Nab-P is effective in the treatment of advanced NSCLC in elderly patients. The adverse reactions are mild and tolerant, and it is worthy to be popularized. Key words: Carcinoma, non-small-cell lung; Nanoparticle albumin-bound paclitaxel; Drug therapy; Elderly

MTE 22.02 Treatment Options in Advanced Non-Small Cell Lung Cancer (NSCLC) in the Elderly: An Evolving Landscape

MTE 22.02 Treatment Options in Advanced Non-Small Cell Lung Cancer (NSCLC) in the Elderly: An Evolving Landscape

Prognostic role of a comprehensive geriatric assessment on the management of elderly patients with advanced non-small cell lung cancer (NSCLC): a pooled analysis of two prospective phase II trials by the GFPC Group.

The prognostic role of a comprehensive geriatric assessment (CGA) on the management of elderly patients with advanced-stage non-small cell lung cancer (NSCLC) remains to be established. The objective of this analysis was to determine the prognostic role of each CGA domain on overall survival (OS) among elderly patients with advanced-stage NSCLC. We pooled individual data from two prospective, randomized phases II trials in patients over 65 years old with advanced-stage NSCLC, who were considered fit (0405 trial) or no-fit (0505 trial) based on a CGA. Both trials compared first-line chemotherapy followed by second-line erlotinib with the reverse strategy in terms of progression-free survival (PFS) and OS. Factors prognostic of OS were sought by using the Kaplan-Meier method and the log rank test for univariate analysis, and a Cox model for multivariate analysis. Analysis performed on 194 patients (mean age: 77 years, male gender: 70%, never- or ex-smokers: 56%) showed, in univariate analysis that performance status (PS), smoking status, Charlson, simplified Charlson, nutritional scores, and a mobility score were prognostics of OS. In multivariate analysis, PS [HR: 1.4 (1.02-1.9), P=0.04] and the Charlson score [HR: 1.46 (1.07-1.99), P=0.02] were independently prognostic of OS, while the nutritional score [HR: 0.69 (0.46-1.04), P=0.07] and the mobility score [HR: 0.25 (0.06-1.01), P=0.06] were close to significance. PS and comorbidities appear to be the main predictors of OS in elderly advanced NSCLC patients selected on the basis of CGA.

Comprehensive geriatric assessment and traditional Chinese medicine intervention benefit symptom control in elderly patients with advanced non-small cell lung cancer.

The aim of this study was to observe the symptom improvement and clinical benefit in elderly patients with advanced non-small cell lung cancer (NSCLC) stratified on the basis of CGA findings after treatment with a combination of traditional Chinese medicine and Western medicine. Twenty-four elderly advanced NSCLC patients with a mean age of 73.0 ± 5.3 (65-83) years were categorized into three stratifications according to CGA results, namely function independent, mildly function impaired, and function dependent. They received standardized therapy, individualized therapy, and best supportive care, respectively. The patients receiving standardized therapy and individualized therapy were randomized into two groups, with or without traditional Chinese medicine for symptom control, while for all the patients receiving best supportive care, traditional Chinese medicine was administered. Nine non-elderly NSCLC patients (<65 years old) were enrolled as control and treated in accordance with NCCN NSCLC treatment guidelines. EORTC QLQ-C30 core scale, LC13 scale, and MDASI-TCM scale were used to assess relevant symptoms before and after treatment. After treatment for 3 weeks, it was shown by QLQ-C30+LC13 scales, for function-dependent patients, that the physical and role performances and the global health status were improved and the symptoms of fatigue and cough were alleviated; by MDASI-TCM scale, the symptoms of fatigue, cough, and expectoration were improved. In function-independent and mildly function-impaired elderly patients, there were no significant changes in functional status and symptoms. But in non-elderly patients, the physical and social performances were lowered, and the symptoms of fatigue, constipation, and poor appetite were aggravated. The elderly patients with advanced NSCLC were categorized on the basis of CGA findings, and traditional Chinese medicine may be beneficial to symptom control of function-dependent patients.

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.

Doublets versus single-agent therapy as first-line therapy for elderly patients with advanced non-small cell lung cancer? A systematic review of randomised controlled trials

Although the standard treatment for advanced non-small cell lung cancer (NSCLC) patients is platinum-based doublet chemotherapy, single-agent therapy is still preferred in elderly patients. Comparison of the efficacy of various combinations of doublets with single-agent chemotherapy is somehow contradictory. This study conducted a systematic review to evaluate the efficacy and tolerability of the third-generation agent-based doublets vs. single-agent chemotherapy in elderly NSCLC patients. Electronic (PubMed, EMBASE and Cochrane Library database) and manual searches were conducted to collect data from published, randomised, phase 2 and 3 trials which compared doublets with a third-generation single-agent chemotherapy in elderly patients. Pooled relative risks (RRs) were calculated for the incidences of overall response rate (ORR), 1-year survival rate (1-y SR), and grade 3/4 toxicities. Seven eligible trials (2219 patients) were selected from 1170 studies that were initially identified. A significant difference in ORR favouring doublets over single agents was observed [RR, 1.59; 95% confidence interval (95% CI), 1.36-1.86; p<0.0001] with a slightly, but not significantly improved 1-y SR (RR, 1.19; 95% CI, 0.98-1.45, p=0.007). Subgroup analysis suggested that platinum (RR, 1.94; 95% CI, 1.47-2.55, p<0.0001) or non-platinum- (RR, 1.45; 95% CI, 1.20-1.75, p<0.0001) based doublets could improve ORR, and the grade 3/4 thrombocytopaenia (RR, 6.64; 95% CI, 1.78-24.86, p=0.005) and anaemia (RR, 2.86; 95% CI, 1.62-5.05, p<0.0001) were preferred to occur in platinum-based doublets. Doublets appear to be more effective and tolerable than single-agent therapy for treating elderly advanced NSCLC patients, and therefore could be considered as a treatment option for elderly populations with good physical status.

Platinum-containing regimens as front-line treatment of advanced non-small cell lung cancer in two groups of elderly (≥ 70 year old) patients of different age.

e20617 Background: Elderly patients with advanced Non-Small Cell Lung Cancer (NSCLC) are underrepresented in clinical trials. Therefore we sought to evaluate the impact of a platinum-based doublet, given as a front-line chemotherapy, in two groups of elderly patients of different age with advanced NSCLC. Methods: A retrospective analysis of all consecutives elderly patients ( ≥70 year old) with advanced NSCLC who received a platinum based doublet as front line therapy at our Medical Oncology Unit from February 2005 to September 2011 was performed. The general case study was divided in two groups of patients of different age: “young-old” patients (70-74 year-old) and “old-old” patients (75-81 year-old). Results: Sixty-two consecutive elderly patients with advanced NSCLC were included in this study. Forty patients (65%) were “young-old” patients (group 1, median age 72 years) and 22 (35%) were “old-old” patients (group 2, median age 77 years). Overall, a total of 249 cycles were administered to the 62 patients; 164 cycles were administered to patients in group 1 and 85 cycles were given to patients in group 2; median number of administered cycles per patient was 4 (range 1-6) in both groups. Relevant clincal variables such as sex, stage, ECOG PS, Charlson score and histology were evenly distributed between the two subgroups. Regarding the type of first line chemotherapy, the great majority (92%) was treated with a carboplatin-containing regimen while only five patients (8%) received a cisplatin-based doublet: notably, all these patients are in group 1. Toxicity was mild, with grade 3-4 neutropenia in 17% of group 1 patients and in 9% of group 2 patients. Median OS was 9.8 months in both groups. Conclusions: This retrospective evaluation shows the safety and efficacy of a platinum-based doublet given as first-line chemotherapy in elderly advanced NSCLC patients. For several reasons, including the ease of administration, carboplatin is the preferred platinum analogue. The combination with vinorelbine or gemcitabine is associated with a very good toxicity profile that does not seem to have a detrimental effect on efficacy.

Efficacy and safety of pemetrexed or gemcitabine combined with carboplatin as the first-line therapy in elderly patients with advanced non-small cell lung cancer

To observe the clinical efficacy and safety of pemetrexed or gemcitabine combined with carboplatin as the first-line therapy in elderly patients with advanced non-small cell lung cancer (NSCLC). Seventy patients aged 70 years or over with stage IIIb-IV NSCLC were equally and randomly divided into pemetrexed plus cisplatin group (PC) and gemcitabine plus carboplatin group (GC). Patients in the PC group received pemetrexed (PEM) 500 mg/m(2) on day 1, and carboplatin (CBP) AUC5 on day 1 for 21-day cycle. Patients in the GC group received gemcitabine 1000 mg/m(2) on days 1 and 8, CBP AUC5 on day 1 for a 21-day cycle. In the PC and GC groups, CR 0 and 0, PR 10 and 8, response rates 28.6% and 22.9% were observed, respectively. There was no statistically significant difference between the two groups (χ(2) = 0.299, P = 0.584). The 1-year and 2-year survival rates of the PC and GC groups were 48.6% vs. 45.7% and 11.4% vs. 11.4%, respectively, with a median survival of 11.00 and 10.00 months, without a statistically significant difference between the two groups (χ(2) = 0.01, P = 0.919). Regarding toxicities, the incidences of neutropenia/thrombocytopenia, nausea and vomiting (grade III ∼ IV) in the GC group were significantly higher than those in the PC group (P < 0.05). According to the observer scale of lung cancer symptoms, the post-treatment scores improved in both the two groups, and with no significant difference between them (P > 0.05). PC and GC show similar efficacy for elderly NSCLC patients, however, the toxicities in PC patients are lower than those in GC patients. Thus, pemetrexed combined with carboplatin is an effective chemotherapeutic regimen for advanced NSCLC in elderly patients.

Metastatic non-small-cell lung cancer (NSCLC): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up

Metastatic non-small-cell lung cancer (NSCLC): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up

1354 - Phase II Trial of Single-Agent Pemetrexed in Chemonaive Elderly Patients with Advanced Non-Small-Cell Lung Cancer (NSCLC) and its Accrual Rate in a Community-Based Clinical Trial Group: LCEN1001

ABSTRACT Background Optimal treatment for elderly patients with advanced NSCLC has been under investigation. This study evaluated the safety and efficacy of single-agent pemetrexed for elderly patients with advanced NSCLC. Moreover, the reasons that prevented accrual and the preferential regimen for such patients in a community-based group were investigated. Patients and methods Chemonaive elderly (≥ 70 years) patients with stage IIIB/IV non-squamous NSCLC received 500 mg/m2 of pemetrexed (day 1, every 3 weeks) for 4-6 cycles. As a QOL assessment, FACT-L lung cancer symptom subscale and Comprehensive Geriatric Assessment were also evaluated. Moreover, clinical trial enrollment decisions were noted. Results From May 2010 to October 2011, 193 consecutive patients were diagnosed as chemonaive elderly (≥ 70 years) patients with stage IIIB/IV non-squamous NSCLC. Among them, 25 patients were enrolled in phase II trial. Characteristics were m/f, 19/6; median age, 78 years (range 70-89); PS 0/1/2, 6/18/1; stage IIIB/IV, 6/19. After a median of 4 cycles of pemetrexed, the ORR and DCR were 16.0% and 68.0%, respectively. Furthermore, the median PFS was 126.0 days and the median OS was not reached. Grade 3/4 hematologic toxicity consisted of leukopenia (20%), neutropenia (24%), thrombocytopenia (4%), and anemia (12%), whereas grade 3/4 nonhematologic toxicity consisted of nausea (4%), anorexia (12%), fatigue (8%), pneumonitits (G3, 8%), febrile neutropenia (0%), and treatment-related death (0%). Among 168 patients who were not enrolled in the trial, 83 and 85 patients were eligible and ineligible, respectively. Therefore, the accrual rate was 25 (23.1%) of 108 eligible patients and 25 (13.0%) of total 193 patients, whereas ineligible rate was 85 (44.0%) of total 193 patients. The most common reason for not participating in the trial despite appropriate eligibility was the preference of platinum doublet chemotherapy (57.8%), whereas the most common treatment choice for ineligible patients was best supportive care (67.1%). Conclusions Single-agent pemetrexed has shown moderate activity and is well tolerated as first-line treatment for advanced NSCLC in elderly patients. However, in our community-based clinical trial group, platinum doublet chemotherapy was the preferential regimen for such patients. Disclosure All authors have declared no conflicts of interest.

Carboplatin and Gemcitabine in First-Line Treatment of Elderly Patients with Advanced Non-Small Cell Lung Cancer: Data from a Retrospective Study

We retrospectively evaluated elderly patients with advanced non-small cell lung cancer (NSCLC) treated with carboplatin (AUC 4-5) and gemcitabine (1,000-1,200 mg/m2). Thirty-six patients with performance Status (PS) 0-1 and median age 73 (range 70-78 years) were considered. Histology was squamous cell carcinoma (8 patients), adenocarcinoma (22) and NSCLC not otherwise specified (6). 149 cycles of chemotherapy were administered with a median of 3 per patient (range 3-6). Grade 3 non-hematologic toxicities were dyspnea (1 patient) and fever (1). Grade 3/4 hematologic toxicities were anemia (6), neutropenia (6) and thrombocytopenia (10), with dose reduction required in 13 patients. the overall disease control rate was 44.4%. We recorded no complete response, 8 partial response, 8 stable disease and 20 progressive disease. After a medium follow-up of 11 months, median progression-free survival and median survival were 5 and 11 months, respectively. Carboplatin and gemcitabine is a safe and active regimen in elderly advanced NSCLC patients with good PS.

Phase II study of biweekly carboplatin and paclitaxel as first-line treatment for elderly patients with advanced non-small cell lung cancer.

e18013 Background: Incidence of elderly advanced non-small cell lung cancer (NSCLC) is increasing and the establishment of optimal treatment for the elderly patients is desired. Currently, as the elderly are underrepresented in clinical trials, only limited data exist. Standard chemotherapy by platinum doublet of elderly patients with advanced NSCLC is still controversial. This study has been conducted to assess the efficacy and toxicity of biweekly carboplatin plus paclitaxel in elderly patients with advanced NSCLC. Methods: Patients ≥70 years old with cytological or histological confirmation of advanced (stage IIIB/IV) NSCLC were included. Other eligibility criteria were PS≤2, measurable lesions according RECIST criteria, adequate organ function. Patients with prior systemic therapy for NSCLC and/or symptomatic brain metastases were not allowed. Patients received biweekly paclitaxel 90 mg/m2 and carboplatin 2.5 AUC on days 1 and 14 of each 28-day cycle. The primary endpoint was the overall response rate (ORR), and secondary endpoints were progression-free survival (PFS), overall survival, and the toxicity profile. Results: We enrolled 47 pts from multiple institutions (Jan. 2007 – Oct. 2010). Males were 76.6%, median age was 77 years (range 70-85). PS was 0-1 in 95.7%. The median number of treatment cycle was 3 (1-6). The objective responses were CR 0; PR 10; SD 12; PD 14; and NE 11, resulting in an ORR of 21.3% (95% confidence interval [CI], 9.6- 33.0). The overall disease control rate was 46.8% (95% CI, 32.5-61.1). Median PFS was 4.17 month (95% CI: 2.18- 6.16). Hematological toxicities of grade 3/4 included neutropenia (28%), leucopenia (19%) and anemia (11%). Nonhematological toxicities (all grade 3) included infusion reaction (2%), anorexia (2%), infection (13%), thrombosis (2%), fatigue (2%), diarrhea (2%) and gastrointestinal bleeding (2%). No grade 4 nonhematological toxicity was observed. There was 1 possible treatment-related death due to interstitial pneumonia. Conclusions: The combination of biweekly carboplatin and paclitaxel is an active first line treatment with a tolerable toxicity profile for advanced NSCLC in elderly patients.

A multicenter phase II randomized study of gemcitabine (G) weekly followed by erlotinib (E) after progression versus E followed by G after progression in advanced non-small cell lung cancer (NSCLC) in vulnerable elderly patients selected with a comprehensive geriatric assessment (CGA) (GFPC*0505).

e18002 Background: Elderly patients (pts) are a heterogeneous population in which anticancer therapeutic decision is often difficult. The objective of this study was to evaluate the feasibility and activity of weekly G followed by E after progression versus E following by G after progression in vulnerable elderly advanced NSCLC patients selected on the basis of a CGA and Charlson score (CS). Methods: This multicenter phase II study randomized chemonaive pts with stage IV and IIIB with pleural effusion received G 1,250mg/m2 days 1, 8, for a maximum of 18 weeks or until progression, followed by E until second progression (arm A) versus E in first line followed by G until second progression (arm B).Only vulnerable pts (without dependence for ADL and geriatric syndrome) selected by CGA using a software (EGSK) included in a palm assistant with 10 items: socio-economic conditions, cognitive assessment, depression scale, nutritional risk, quality of life(QOL), ADL, IADL (Lawton), incontinence, falls, pain. Major endpoint was time to second progression (TTP2), secondary endpoints were response, time to first progression (TTP1), safety, QOL. Results: 95 pts (67 available today) were enrolled from Aug 2006 to Dec 2009. Patients: Male/Female 54/13, median age 78.1; PS 0/1/2:22/33/10, median co-morbidity (CS) 1.85 (1-3), median IADL score 3.48 (1-4), median global geriatric index: 17.7/20. Respectively for arm A and B, partial response was 18% and 7%, stable disease 18% and 27%, progressive disease 64% and 67%,TTP1 81 and 63 days, median survival 4.3 and 3.9 months. The main WHO grade 3/4 toxicity was anemia 12.5% and fatigue 12.5% in arm A and fatigue 28.6% and anemia 5.7% in B. Conclusions: Preliminary analysis suggests that either the G followed by E or E followed by G appears to have acceptable toxicity but moderate activity, comparable in terms of efficacy to prior data in this vulnerable elderly NSCLC pts population with significant co-morbidities. Our trial confirms the necessity to identify the better tools in CGA to distinguish frail pts. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Amgen, Boehringer Ingelheim, Lilly, Roche Amgen, Lilly, Roche Amgen, Lilly, Roche

A multicenter phase II randomized study of docetaxel (D)/gemcitabine (G) weekly followed by erlotinib (E) after progression versus erlotinib followed by docetaxel/gemcitabine after progression in advanced non-small cell lung cancer (NSCLC) in fit elderly patients selected with a comprehensive geriatric assessment (CGA): Groupe Français de Pneumocancerologie (GFPC)*0504.

7536 Background: Elderly pts is an heterogeneous population in which anticancer therapeutic decision is often difficult. The objective of this study was to evaluate the feasibility and activity of weekly D/G followed by E after progression versus E following by D + G after progression in fit elderly advanced NSCLC patients selected on the basis of a CGA and Charlson score. Methods: This multicenter phase II study randomized chemonaive pts with stage IV and IIIB with pleural effusion received D 30 mg/m2 weekly for 6 consecutive weeks (wks) plus G 900 mg/m2 days 1, 8, 22, 29 followed by 2 wks off, for a maximum of 24 wks or until progression, followed by E until second progression (arm A) versus E in first line followed by D+G until second progression (arm B). Only fit pts (without dependence for ADL or IADL and geriatric syndrom) selected by CGA using a software (EGSK) included in a palm assistant with 10 items: socio-economic conditions, cognitive assessment,depression scale, nutritional risk, quality of life (QOL), ADL, IADL, incontinence, falls, pain. Major endpoint was time to second progression (TTP2), secondary endpoints were response, time to first progression (TTP1), safety, QOL. Results: 100 pts (99 available) were enrolled from July 2006 to November 2008. Patients: Male/Female 59/40, median age 75.9; PS 0/1/2:43/49/6, median comorbidity 0, 4 (0-4) median global geriatric index: 18.5/20. Respectively for arm A and B: partial response was 26.3% and 18.8%, stable disease 42.1% and 33.3%, progressive disease 31.6% and 47.9%,TTP1: 4.7 and 3.1 months, TTP2: 7.7 and 6.6 months, median survival 9.4 and 7.1 months. The main WHO grade 3/4 toxicity was neutropenia 29.2% and fatigue 10.4% in arm A and fatigue 11.8% and cutaneous 11.8% in B. Conclusions: Preliminary analysis suggests that either the combination of weekly D and G followed by E or E followed by D+G appears to be promising with a favourable toxicity profile in fit elderly NSCLC pts with mild comorbidity. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Amgen, Boehringer Ingelheim, Lilly, Roche Amgen, Lilly, Roche Amgen, Lilly, Pfizer, Roche, sanofi-aventis

Treating advanced non-small cell lung cancer in the elderly.

More than 40% of cases of all lung cancers are diagnosed in patients over the age of 70 years. Elderly patients have more comorbidities and tend to be less tolerant to toxic medical treatments than their younger counterparts. Thus, clinical data obtained in a younger population cannot be automatically extrapolated to the great majority of nonselected elderly patients with non-small cell lung cancer (NSCLC). The bulk of prospective clinical data regarding chemotherapy and molecularly targeted therapy for elderly NSCLC patients come from studies in advanced disease. In elderly advanced NSCLC patients, single-agent chemotherapy with third-generation agents (vinorelbine, gemcitabine, taxanes) is to be considered the routine standard of care for unselected patients, based on phase II and III trials specifically designed for this special population. Cisplatin-based chemotherapy with cisplatin at attenuated doses has been demonstrated to be an active and feasible option in phase II trials. Among targeted therapies, the epidermal growth factor receptor tyrosine kinase inhibitors, erlotinib and gefitinib, have relevant phase II prospective data showing activity and good tolerability as first-line treatment in this population. Concerning the antivascular endothelial growth factor monoclonal antibody, bevacizumab, combined with chemotherapy, particular care must be taken for elderly patients because of the higher incidence of cardiovascular comorbidities. The lack of data on octogenarians suggest that clinicians should exercise caution when applying the existing data on chemotherapy and targeted therapies for patients aged 70-79 years to those aged >80 years. Further specifically designed clinical trials are needed to optimize medical treatment of NSCLC in elderly patients.

Efficacy study of single-agent gemcitabine versus gemcitabine plus carboplatin in untreated elderly patients with stage IIIb/IV non-small-cell lung cancer

To explore a chemotherapeutic regimen suitable for non-small cell lung cancer (NSCLC) in elderly patients. A total of 68 elderly patients with NSCLC (stage IIIb/IV) were equally and randomly divided into single-agent and combined groups. Patients in single-agent group received gemcitabine 1000 mg/m(2) at Days 1 and 8 for a 21-day cycle. Those in combined group received gemcitabine 1000 mg/m(2) at Days 1 and 8 in combination carboplatin AUC5 at Day 2 for a 21-day cycle. The drugs were intravenously administered. All patients received 3 cycles of treatment. In single-agent and combined groups, CR 1 and 1, PR 12 and 13, response rates 38% and 41% were respectively observed. There was no statistically significant difference between two groups (P > 0.05). The 1-year and 2-year survival rates of single-agent and combined groups were 31% vs 32% and 12% vs 14% with a median survival of 9.9 and 9.8 months without a statistically significant difference (P > 0.05). The rates of leucopenia and thrombocytopenia (III-IV degree) were 47% and 38% in combined group and they were higher than 24% and 15% in single-agent group with a statistically significant difference (P < 0.05). The observer scale of lung cancer symptom scale showed that the post-treatment scores of appetite, fatigue and pain significantly improved in single-agent group while no improvement was observed in combined group. Also the scores of appetite, fatigue and pain of single-agent group were higher than those of combined group after chemotherapy (P < 0.05). Single-agent gemcitabine regimen is more suitable for advanced NSCLC in elderly patients.

Clinical Observation of Erlotnib in the Treatment of Non-small Cell Lung Cancer with Multimetastases in Elderly Patients.

Erlotnib is the inhibitor of epidemic growth factor receptor and mainly used to treat non-small cell lung cancer (NSCLC). The aim of this study is to evaluate the antitumor efficacy and toxicity of erlotnib in the treatment of Chinese elderly NSCLC patients with multimetastases. Tirty-three Chinese elderly NSCLC patients with multimetastases received 150 mg of erlotnib orally once daily until disease progressing or intolerable toxic developing. Tirty patients were evaluable for therpeutic effect. Without complete regression being observed, 6 patients got partial resonse (PR, 20%), 16 stable disease (SD, 53.33%) and 8 progressive disease (PD, 26.68%). The total response rate was 20.0% and disease control rate including both tumor response and stable disease was 73.3%. On the pathology, compared with the patients with squamous cell carcinoma, those with adenocarcinoma had not significant longer median overall (13.592+/-1.914 months vs 9.846+/-1.598 months, P=0.301) and progression-free survival times (7.367+/-0.923 months vs 6.615+/-1.366 months, P=0.488), The median survival was sigificantly related with meningeal metastasis, metastasis of liver, pleural efusion using survival analysis. The main toxicities of erlotnib were skin toxicity (rash) and diarrhea with no need of further treatment. Erlotnib demonstrates significant antitumor activity and a favorable tolerability profile in Chinese elderly advanced NSCLC patients with multimetastases.

Trends in chemotherapy for elderly patients with non-small cell lung cancer: The experience of one institution

e19081 Background: In approximately the year 2000, the results of a number of important studies of non-small-cell lung cancer (NSCLC) were published. These included the first elderly-specific phase III trial and phase III trials showing a survival benefit for docetaxel when used as second-line chemotherapy. These results had a significant impact on clinical practice relating to advanced NSCLC in elderly patients. Methods: Between July 1992 and December 2003, 223 patients with NSCLC aged ≥70 years received chemotherapy alone as their initial treatment at the National Cancer Center Hospital East. These patients were divided into 2 groups: those that began treatment between 1992 and 1999 (group A) and between 2000 and 2003 (group B). The details of chemotherapy regimens and outcomes were compared. Results: In group A, 83% of patients received platinum-based chemotherapy, two-thirds of these regimens comprised platinum[[Unsupported Character - ]]plus second-generation combination chemotherapy. In contrast, although 55% of patients received platinum-based chemotherapy in group B, 41% of patients received non-platinum-based chemotherapy. Among patients in group B, performance status was significantly associated with the selection of platinum-based or non- platinum-based chemotherapy; age was marginally associated with this selection. In group A, second-line chemotherapy was administered to only 4 patients (5%) and no patients received third-line chemotherapy. In group B, second-line and third-line chemotherapy was administered to 62 (42%) and 22 (15%) patients, respectively. Median survival time (MST), 1-year survival rate, and 2 year-survival rate were 6.7 months, 14%, and 7%, respectively, in group A, and 8.1 months, 35%, and 20% in group B (p = 0.0109). However, these differences disappeared when patients treated with epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) were removed from the analysis (6.7 months in group A vs. 6.9 months in group B, p = 0.3684). Conclusions: In and after the year 2000, chemotherapy regimens changed greatly and survival of elderly patients significantly improved. However, the improvement in survival seems to be due mostly to the use of EGFR-TKI treatment. No significant financial relationships to disclose.

Is the platinum-based chemotherapy necessary for elderly patients with advanced non-small cell lung cancer (NSCLC)?

19088 Background: Single-agent chemotherapy as a first-line treatment is currently considered as the standard approach for elderly patients with advanced NSCLC. Since the platinum-based combination chemotherapy is the standard treatment for younger patients with advanced NSCLC, it may also have more effective for elderly. We reviewed the chart records of elderly advanced NSCLC patients treated with any chemotherapy in our hospital. Methods: We undertook retrospective reviews in 178 elderly advanced NSCLC patients, who were more than 70 years old and received any chemotherapy in our hospital from 1996 to 2005. Survival curves were made up by Kaplan-Maier method and compared using the log-rank test. Multivariate analysis was performed by the Cox’s proportional hazard model. Results: In 178 elderly patients, 109 (61.2%) aged 70–74 years old and 69 (38.8%) aged 75 years or older were classified. There was no difference in backgrounds, which were gender, histology (adenocarcinoma or non-adenocarcinoma), and ECOG PS (0–1 or 2), between the two groups. However, there was significant difference of the treatment regimen (platinum-based combination or single agent [non platinum- based]) when we made the determination on the basis of our treatment policy. Platinum-based chemotherapy was selected more in aged 70–74 patients (65 pts; 59.6%) than aged 75 years or older patients (16 pts; 23.2%), therefore, single agent chemotherapy was more selected for aged 75 years or older patients. There was no statistical difference in median overall survival with platinum-based chemotherapy group and non platinum-based chemotherapy group (10.4 months vs 9.9 months, P =0.3647). The prognostic factors in multivariate analysis were PS 0–1, female, and adenocarcinoma, but platinum-based chemotherapy was not good prognostic factor, furthermore, patients aged 75 years or older had not poor survival. Conclusions: Platinum-based chemotherapy was not necessary for elderly patients with advanced NSCLC in this review. While retrospective studies have several limitations, prospective randomized controlled trial comparing platinum-based chemotherapy with single agent chemotherapy for elderly patients with advanced NSCLC is conducted in Japan. No significant financial relationships to disclose.

First-line chemotherapy with planned sequential administration of gemcitabine (G) followed by docetaxel (D) in elderly advanced non-small-cell lung cancer (NSCLC) patients: A multicenter phase II study

19092 Background: Single-agent chemotherapy (G or vinorelbine) is currently a standard treatment for elderly advanced NSCLC patients. The combination of G+D was active but not well tolerated in thi...