A randomized phase II trial of pemetrexed/gemcitabine/bevacizumab or pemetrexed/carboplatin/bevacizumab in the first-line treatment of elderly patients with advanced non-small cell lung cancer.

Spigel, David R.; Greco, F. Anthony; Shipley, D.; Ervin, Thomas J.; Lubiner, Eric T.; Peyton, James D.; Barnes, Edward K.; Thompson, Dana S.; Burris, HA; Hainsworth, John D.

doi:10.1200/jco.2010.28.15_suppl.7593

Cited by 8 publications

(16 citation statements)

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“…The main design characteristics and treatment outcomes of these studies are summarized in Table V. A total of 5 studies were phase II studies (10-14), 1 was a population-based study (16), and only 1 was an observational study with similar design characteristics to the present study (15). The present study results of a median PFS time of 8 months, and a range of OS times of between 12 and 16 months are similar to those reported in these previous trials, in which the shortest PFS time was 5.6 months in the population-based study by Nakamura et al (2012) (16) and the longest was 10.2 months in the phase II study by Spigel et al (2012) (12). For OS, the shortest median was 12.6 months in the PointBreak study by Patel et al (2013) (13) and the longest was 19.3 months in the population-based study by Nakamura et al (2012) (16).…”

Section: Discussionsupporting

confidence: 91%

“…The only study with a design similar to the present study, i.e., an observational, single-center study, was that by Malhotra et al (2010), which did not report median OS and PFS times, but did report response rates (RR) and actuarial survival percentages: 52% of patients exhibited a PR, disease control was documented for 40%, and the actuarial OS and PFS rates after 12 months were 83 and 63%, respectively. The corresponding results of the present study were lower than this, but high overall; in terms of RR, the results were close to the 34.1% reported in the PointBreak study (13) and the 35% reported in the study by Spigel et al (12). In terms of disease control, the present results lie within the range reported by the remaining studies, with the lowest rate of 30.4% reported in the study by Yokoi et al (14) and the highest rate of 65.9% in the PointBreak study (13).…”

Section: Discussionsupporting

confidence: 78%

“…Currently, the combination of bevacizumab plus pemetrexed and a platinum agent has emerged as an important first-line treatment for non-squamous NSCLC. To date, findings with this combination have been reported in only 7 studies: The first phase II study in 2009 (10), 4 further phase II studies (11)(12)(13)(14), 1 observational study (15) and 1 population-based study (16). Furthermore, published data for the administration of this combination to patients with brain metastases (BM) have been reported for only few cases, and no comparisons of survival between patients with and without BM are available.…”

Section: Introductionmentioning

confidence: 99%

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Bevacizumab, pemetrexed and carboplatin in first-line treatment of non-small cell lung cancer patients: Focus on patients with brain metastases

et al. 2016

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Abstract. Data concerning bevacizumab plus pemetrexed plus carboplatin as first-line treatment for patients with non-squamous non-small cell lung cancer (NSCLC) with or without brain metastases (BM) are lacking. The present study analyzed the efficacy and safety of this combination as induction therapy, followed by maintenance therapy with bevacizumab plus pemetrexed in non-squamous NSCLC patients with or without BM. Treatment-naïve patients with advanced non-squamous NSCLC and an Eastern Cooperative Oncology Group performance status score of 0-2 were eligible. Treatment consisted of carboplatin (area under the curve of 5), pemetrexed (500 mg/m 2 ) and bevacizumab (15 mg/kg) every 3 weeks for 6 cycles. Responders and patients with stable disease received maintenance therapy with bevacizumab plus pemetrexed until disease progression, which was evaluated every 3 cycles, or unacceptable toxicity. Kaplan-Meier median progression-free survival (PFS) and overall survival (OS) times were the primary endpoints, and safety was the secondary endpoint. In total, 39 patients, aged 44-78 years (median, 60 years), were treated; 11 (28.2%) of whom presented with BM. The majority of patients (56.4%) completed 6 cycles of induction therapy, and 26 patients continued on to maintenance therapy. The median PFS time was 8.2 months [95% confidence interval (CI), 7.05-9.35] and the median OS time was 14.0 months (95% CI,). Median PFS and OS times did not differ significantly between patients with or without BM (log rank (Mantel-Cox): PFS, P=0.748 and OS, P=0.447). The majority of patients (76.9%) did not experience adverse events during treatment. Overall, bevacizumab plus pemetrexed plus carboplatin as induction therapy, followed by bevacizumab plus pemetrexed as maintenance therapy was effective and well tolerated in advanced NSCLC, whether brain metastases were present or not. IntroductionLung cancer is the leading cause of cancer-related mortality worldwide (1). The age-standardized (world) lung cancer mortality rate in Greece shows that one in two cancer-related mortalities in men are caused by lung cancer (50%); the figure for women is much lower at 6.3% (2). The majority of patients (70%) exhibit advanced disease at the time of diagnosis (3), and 5 years after diagnosis, only 16.6% of patients remain alive (4).Research in the field of more effective management of lung cancer is clearly worthwhile, with the goal of increasing survival while maintaining quality of life, and promising advances have been made. The current standard of care for advanced non-small cell lung cancer (NSCLC) is cytotoxic combination chemotherapy with a platinum compound (carboplatin or cisplatin) and one other agent, such as pemetrexed, vinorelbine, paclitaxel, gemcitabine or docetaxel (5,6). Therapy is usually administered for a maximum of 6 cycles unless the disease progresses or there is no response (6).Pemetrexed inhibits thymidylate synthase and other folate-dependent enzymes involved in the metabolism and synthesis of DNA precursors. A phase III ra...

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Section: Discussionsupporting

confidence: 91%

Section: Discussionsupporting

confidence: 78%

Section: Introductionmentioning

confidence: 99%

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Bevacizumab, pemetrexed and carboplatin in first-line treatment of non-small cell lung cancer patients: Focus on patients with brain metastases

et al. 2016

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“…15 Improved TTP and OS were observed in the pemetrexed, carboplatin, and bevacizumab arm at 10.2 months and 14.8 months, respectively, and the response rate was 35%. These findings are comparable to our results as well as those of Patel and colleagues with doublet maintenance therapy.…”

Section: Discussionmentioning

confidence: 96%

Phase 2 trial of maintenance bevacizumab alone after bevacizumab plus pemetrexed and carboplatin in advanced, nonsquamous nonsmall cell lung cancer

Stevenson

Langer

Somer

et al. 2012

Cancer

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BACKGROUND: The authors performed a phase 2 study of bevacizumab plus pemetrexed and carboplatin followed by maintenance bevacizumab in patients with advanced, nonsquamous nonsmall cell lung cancer. METHODS: Previously untreated patients with advanced, nonsquamous nonsmall cell lung cancer and an Eastern Cooperative Oncology Group performance status of 0 or 1 received bevacizumab 15 mg/kg, pemetrexed 500 mg/m2 and carboplatin at an area under the concentration‐time curve of 6 intravenously on day 1 every 21 days. Responding or stable patients who completed 6 cycles then received bevacizumab maintenance every 21 days until disease progression. RESULTS: In total, 43 patients (40 who were evaluable for response) were entered on the study. Treatment‐related grade 3/4 toxicities were low and included febrile neutropenia (2%), neutropenia (28%), anemia (18%), thrombocytopenia (11%), hypertension (7%), epistaxis (5%), venous thrombosis (8%), dyspnea (7%), rectovaginal fistula (2.3%), infusion reaction (2%), and cerebrovascular event (2%). One patient died from complications of venous thromboembolism and cerebrovascular accident after Cycle 2. Minimal clinically significant toxicity occurred during maintenance bevacizumab. Two complete responses (5%) were observed, and 17 patients (42%) had a partial response. Fifteen patients (38%) displayed disease stability. The overall disease control rate was 85%. At a median follow‐up of 15.8 months, the median progression‐free survival was 7.1 months (95% confidence interval, 5.9‐8.3 months), and the median overall survival was 17.1 months (95% confidence interval, 8.8‐25.5 months). CONCLUSIONS: Combined bevacizumab, pemetrexed, and carboplatin followed by maintenance bevacizumab was well tolerated and displayed remarkable activity in patients with previously untreated, advanced, nonsquamous nonsmall cell lung cancer. Cancer 2012. © 2012 American Cancer Society.

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“…Irrespectively, a recent meta-analysis of randomized, phase II/III trials adding bevacizumab to platinum-based chemotherapy as firstline treatment in patients with advanced NSCLC confirmed the benefit of bevacizumab on prolonged overall and progression-free survival without unexpected toxicity [Soria et al 2013]. Benefit of this regimen in elderly patients (>65 years), however, is controversial [Laskin et al 2012;Spigel et al 2012;Zhu et al 2012]. Pretreatment measurement of circulating VEGF-A level is of prognostic value in patients receiving bevacizumab [Hegde et al 2013].…”

Section: Vascular Endothelial Growth Factormentioning

confidence: 99%

Targeted therapies in non-small cell lung carcinoma: what have we achieved so far?

Farhat

Houhou

2013

Ther Adv Med Oncol

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Abstract:The search for innovative therapeutic agents in non-small cell lung cancer (NSCLC) has witnessed a swift evolution. The number of targeted drugs that can improve patient outcomes with an acceptable safety profile is steadily increasing. In this review, we highlight current drugs that have already been approved or are under evaluation for the treatment of patients with NSCLC, either in monotherapy or combined therapy for both the first-and second-line settings. Experience with drugs targeting the vascular endothelial growth factor and its receptor, as well as the epidermal growth factor receptor is summarized. Moreover, we provide an overview of more novel targets in NSCLC and initial experience with the respective therapeutic agents.

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A randomized phase II trial of pemetrexed/gemcitabine/bevacizumab or pemetrexed/carboplatin/bevacizumab in the first-line treatment of elderly patients with advanced non-small cell lung cancer.

Cited by 8 publications

References 0 publications

Bevacizumab, pemetrexed and carboplatin in first-line treatment of non-small cell lung cancer patients: Focus on patients with brain metastases

Bevacizumab, pemetrexed and carboplatin in first-line treatment of non-small cell lung cancer patients: Focus on patients with brain metastases

Phase 2 trial of maintenance bevacizumab alone after bevacizumab plus pemetrexed and carboplatin in advanced, nonsquamous nonsmall cell lung cancer

Targeted therapies in non-small cell lung carcinoma: what have we achieved so far?

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