Should Elderly Non–Small-Cell Lung Cancer Patients Be Offered Elderly-Specific Trials? Results of a Pooled Analysis From the North Central Cancer Treatment Group

Jatoi, Aminah; Hillman, Shauna L.; Stella, Philip J.; Green, Erin; Adjei, Alex A.; Nair, Suresh; Perez, Edith A.; Amin, B.; Schild, Steven E.; Castillo, R.; Jett, James R.

doi:10.1200/jco.2005.03.7465

Cited by 114 publications

(69 citation statements)

References 13 publications

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“…However, the SPIRITS trial only involved patients of less than 75 years, and extrapolation of the results from retrospective reviews or meta-analyses to the elderly patients must be done with caution because of the following limitations: (1) a small, approximately 1-month, survival advantage observed in the meta-analysis was achieved at the expense of increased toxicity (Wagner et al, 2006); (2) chemotherapy-related toxicities, such as neutropenia, anaemia, stomatitis and diarrhoea, occurred more frequently in the elderly (Trumper et al, 2006); (3) the early drop out rate was significantly higher and 5-FU dose intensity was significantly lower in the elderly when treated with combination chemotherapy containing 5-FU and cisplatin (Trumper et al, 2006); and (4) QOL, which could be impaired as the intensity of chemotherapy increases, has not been studied sufficiently. Ideally, standard treatment of AGC in elderly patients should not be based solely on retrospective subset analyses of prospective trials, and elderly specific trials are needed to define the optimal treatment for these patients (Perrone et al, 2002;Jatoi et al, 2005). Considering the ORR, OS and safety results, our study provides evidence that elderly patients with AGC could benefit from capecitabine or S-1 monotherapy with minimal adverse events.…”

Section: Discussionmentioning

confidence: 76%

A randomised multicentre phase II trial of capecitabine vs S-1 as first-line treatment in elderly patients with metastatic or recurrent unresectable gastric cancer

et al. 2008

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This randomised multicentre phase II study was conducted to investigate the activity and safety of two oral fluoropyrimidines, capecitabine or S-1, in elderly patients with advanced gastric cancer (AGC). Elderly (X65 years) chemo-naive patients with AGC were randomly assigned to receive capecitabine 1250 mg m À2 two times daily on days 1 -14 every 3 weeks or S-1 40 -60 mg two times daily according to body surface area on days 1 -28 every 6 weeks. Ninety-six patients were enrolled and 91 patients were randomised to capecitabine (N ¼ 46) or S-1 (N ¼ 45). Overall response rate, the primary end point, was 27.2% (95% CI, 14.1 -40.4, 12 of 44 assessable patients) with capecitabine and 28.9% (95% CI, 15.6 -42.1, 13 of 45) with S-1. Median times to progression and overall survival in the capecitabine arm (4.7 and 9.5 months, respectively) were similar to those in the S-1 arm (4.2 and 8.2 months, respectively). The incidence of grade 3 -4 granulocytopenia was 6.8% with capecitabine and 4.8% with S-1. Grade 3 -4 nonhaematologic toxicities were: asthenia (9.1% with capecitabine vs 7.1% with S-1), anorexia (6.8 vs 9.5%), diarrhoea (2.3 vs 0%), and hand -foot syndrome (6.8 vs 0%). Both capecitabine and S-1 monotherapies were active and tolerable as first-line treatment for elderly patients with AGC.

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Section: Discussionmentioning

confidence: 76%

A randomised multicentre phase II trial of capecitabine vs S-1 as first-line treatment in elderly patients with metastatic or recurrent unresectable gastric cancer

et al. 2008

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“…Hence, recruitment efforts must proceed hand-in-hand with initiatives to design practical trials that are readily translated to underrepresented populations. 33 Finally, healthcare providers play a vital role in the successful recruitment of underrepresented patients to cancer clinical trials. Overcoming the barriers that prevent them from recommending clinical trials to their patients is both difficult and complex.…”

Section: Discussionmentioning

confidence: 99%

Provider roles in the recruitment of underrepresented populations to cancer clinical trials

Howerton

Gibbons

Baffi

et al. 2007

Cancer

150

127

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BACKGROUND.Providers play a vital role in the successful recruitment of underrepresented patients to cancer clinical trials because they often introduce the opportunity of clinical trials. The purpose of the current systematic review was to describe provider‐related factors influencing recruitment of underrepresented populations to cancer clinical trials.METHODS.To find original studies on the recruitment of underrepresented populations to cancer clinical trials, electronic databases from January 1966 to December 2005 were searched; hand‐searched titles in 34 journals from January 2003 to January 2006; and reference lists were examined of eligible articles. Title and abstract reviews were conducted to identify relevant studies. Potential articles were then abstracted using a structured instrument and a serial review process by 2 investigators.RESULTS.Eighteen studies were eligible for review: 13 targeted healthcare providers, 3 targeted patients/participants, and 2 targeted both providers and patients. The study designs included randomized controlled trial, concurrent controlled trial, case‐control, descriptive, and qualitative. A lack of available protocols and/or a lack of provider awareness about clinical trials prevented providers from discussing the opportunity of clinical trials in 2 studies. In 14 studies, patient accrual was affected by provider attitudinal barriers relating to patient adherence to the study protocol, patient mistrust of research, patient costs, data collection costs, and/or patient eligibility. Providers' communication methods were barriers in 5 studies and promoters in 1 study.CONCLUSIONS.A heterogeneous body of evidence suggests that several provider‐related factors influence recruitment of underrepresented groups to clinical trials. Future recruitment efforts should address these factors. Cancer 2007;109:465–476. © 2007 American Cancer Society.

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“…Nevertheless, toxicity profile opposite age groups was usually consistent in the literature. Some clinical trials indicated that hematologic toxicity of grade 3 to 4 was higher in elderly patients (Rocha et al, 2002;Schild et al, 2003;Sequist et al, 2003;Jatoi et al, 2005), while the other trials were not (Hensing et al, 2003;Langer et al, 2003;Ansari et al, 2011). Ageing is associated with decreasesing in bone marrow reserve and myelotoxicity may be fairly increased (Deppermann et al, 2001).…”

Section: Efficacymentioning

confidence: 99%

Cisplatin-Based Therapy for the Treatment of Elderly Patients with Non-Small-Cell Lung Cancer: a Retrospective Analysis of a Single Institution

İnal

Kaplan²,

Küçüköner³

et al. 2012

Asian Pacific Journal of Cancer Prevention

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Background: In spite of the fact that platinum-based doublets are considered the standard therapy for patients with advanced non-small-cell lung cancer (NSCLC), no elderly-specific platinum based prospective phase III regimen has been explored. The aim of this retrospective singlecenter study was to evaluate the efficacy and side effects of cisplatin-based therapy specifically for the elderly. Methods: Patients receiving platinum-based treatment were divided into three groups. In the first group (GC), Gemcitabine was administrated at 1000 mg/m 2 on days 1, 8 and cisplatin was added at 75 mg/m 2 on day 1. In the second group (DC), 75 mg/m 2 docetaxel and cisplatin were administered on day 1. The third group (PC) received 175 mg of paclitaxel and 75 mg of cisplatin on day 1. These treatments were repeated every three weeks. Result: GC arm had 36, the DC arm 42 and the PC arm 29 patients. Grade III-IV thrombocytopenia was higher in the GC arm (21.2% received GC, 2.8% received DC, and 3.8% received PC), while sensory neuropathy was lower in patients with GC arm (3.0%, 22.2%, and 23.1% received GC, DC and PC, respectively). There were no statistically significant difference in the response rates among the three groups (p>0.05). The median Progression-free survival (PFS) was 5.0 months and the median Overall survival (OS) in each group was 7.1, 7.4 and 7.1 months, respectively (p>0.05). Conclusion: The response rate, median PFS and OS were similar among the three treatment arms. Grade III-IV thrombocytopenia was higher in the GC arm, while the GC regimen was more favorable than the other cisplatin-based treatmetns with regard to sensory neuropathy.

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Should Elderly Non–Small-Cell Lung Cancer Patients Be Offered Elderly-Specific Trials? Results of a Pooled Analysis From the North Central Cancer Treatment Group

Cited by 114 publications

References 13 publications

A randomised multicentre phase II trial of capecitabine vs S-1 as first-line treatment in elderly patients with metastatic or recurrent unresectable gastric cancer

A randomised multicentre phase II trial of capecitabine vs S-1 as first-line treatment in elderly patients with metastatic or recurrent unresectable gastric cancer

Provider roles in the recruitment of underrepresented populations to cancer clinical trials

Cisplatin-Based Therapy for the Treatment of Elderly Patients with Non-Small-Cell Lung Cancer: a Retrospective Analysis of a Single Institution

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