A randomized, double-blind, phase II study of ramucirumab plus docetaxel vs placebo plus docetaxel in Japanese patients with stage IV non-small cell lung cancer after disease progression on platinum-based therapy

Yoh, Kiyotaka; Hosomi, Yukio; Kondo, Kazuo; Yamada, Kazuhiko; Takahashi, Toshiaki; Yamamoto, Nobuyuki; Nishio, Makoto; Ohe, Yuichiro; Koue, Toshiko; Nakamura, Takashi; Enatsu, Sotaro; Lee, Pablo; Ferry, David; Tamura, Tomohide; Nakagawa, Kazuhiko

doi:10.1016/j.lungcan.2016.07.019

Cited by 96 publications

(93 citation statements)

References 16 publications

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“…In our study, the ORR of DR in the 29 patients administered prophylactic PEG‐G‐CSF appeared to be similar to that of previous studies . Although the efficacy and safety of DR in patients with NSCLC aged > 75 years is unclear, our study indicated that DR is active and tolerable in elderly patients if prophylactic PEG‐G‐CSF is administered.…”

Section: Discussionsupporting

confidence: 88%

Clinical significance of primary prophylactic pegylated‐granulocyte‐colony stimulating factor after the administration of ramucirumab plus docetaxel in patients with previously treated non‐small cell lung cancer

Mouri¹,

Kaira²,

Shiono³

et al. 2019

Thoracic Cancer

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Whether primary prophylactic pegylated‐granulocyte‐colony stimulating factor (PEG‐G‐CSF) should be administered immediately after the initiation of ramucirumab plus docetaxel (DR) to prevent the occurrence of febrile neutropenia (FN) is unclear. Our retrospective study aimed to elucidate whether PEG‐G‐CSF could control the occurrence of FN as a result of DR in patients with previously treated non‐small‐cell lung cancer. Thirty‐three patients with previously treated non‐small‐cell lung cancer who had received DR were eligible for our analysis. Of the 33 patients, 29 received prophylactic PEG‐G‐CSF immediately after DR, but none developed FN. However, FN was observed in 2 (50%) of the 4 patients that were not administered PEG‐CSF. The overall response and disease control rates in the 29 patients with prophylactic PEG‐GSF were 31% and 62%, respectively. The median progression‐free and overall survival rates of the patients with and without prophylactic PEG‐GSF were 177 and 163 days ( P = 0.20), and 628 and 274 days ( P = 0.13), respectively. Primary prophylactic PEG‐G‐CSF suppressed the occurrence of FN secondary to the administration of DR.

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Section: Discussionsupporting

confidence: 88%

Clinical significance of primary prophylactic pegylated‐granulocyte‐colony stimulating factor after the administration of ramucirumab plus docetaxel in patients with previously treated non‐small cell lung cancer

Mouri¹,

Kaira²,

Shiono³

et al. 2019

Thoracic Cancer

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“…And the association between HR OS and 12-month OS milestone ratio appeared to be stronger for secondline studies (R 2 = 0.89;95%CI, 0.72-0.98) than for first-line studies (R 2 = 0.65; 95% CI, 0.20-0.91). Meanwhile, in second-line NSCLC trials that published between 2013 and 2017, [13][14][15][16][17][18][19][20][21][22][23][24][25][26][27][28][29] the median time frame needed for the interim analysis of OS was 28 months (range: 20-48 months), while it was 12 months for 1 yr survival analysis. Collectively, these results indicate the potential of 1 yr survival as a valid SE for OS in second-line NSCLC trials.…”

Section: Discussionmentioning

confidence: 99%

“…12 Although their study did not provide a rigorous SE assessment, their results indicated the potential surrogacy of 1 yr survival for OS in advanced NSCLC. For the second condition, we performed a pre-analysis of recently published (2013-2017) second-line NSCLC trials [13][14][15][16][17][18][19][20][21][22][23][24][25][26][27][28][29] (Supporting Information Table S1). In the pre-analysis, the time frame needed for the interim analysis of OS in each trial was extracted from the published articles or ClinicalTrials.gov to calculate the median time frame.…”

Section: Introductionmentioning

confidence: 99%

Progression‐free survival and one‐year milestone survival as surrogates for overall survival in previously treated advanced non‐small cell lung cancer

Zhang

Hong

et al. 2019

Intl Journal of Cancer

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The advent of immunotherapy leads to greater availability of effective subsequent treatments and extended survival in previously treated advanced non‐small cell lung cancer (NSCLC), complicating the evaluation of overall survival (OS) in second‐line NSCLC trials. Here, we aimed to assess the surrogacy of progression‐free survival (PFS) and milestone survival for OS in second‐line NSCLC trials investigating chemotherapy, targeted therapy and immunotherapy, respectively. We systemically searched for active‐controlled, second‐line NSCLC trials. The milestone time point was set at one‐year based on pre‐analysis. A two‐stage meta‐analytic validation model was adopted to assess associations between surrogate endpoint (SE) and OS and associations between treatment effects on SE and OS. Treatment effects on SE and OS were expressed as PFS hazard ratios (HRPFS), 1 yr‐milestone ratio (Ratio1y‐SUR) and HROS. Subgroup analyses stratified by treatment types and trial publication years evaluated the surrogacy in different clinical contexts. The study included 50 trials with 22,804 patients. One‐year survival strongly correlated with OS (R2[95% confidence interval]: one‐year survival ‐median OS = 0.707 [0.704–0.708]; Ratio1y‐SUR‐HROS = 0.829 [0.828–0.831]). No correlation was established between PFS and OS (median PFS‐median OS = 0.100 [0.098–0.101]; HRPFS‐HROS = 0.064 [0.059–0.069]), except in immunotherapy subgroup (HRPFS‐HROS = 0.835 [0.791–0.918]). In subgroup analyses, surrogacy of one‐year survival persisted in different clinical contexts, and the disassociation between PFS and OS persisted in recent trials. One‐year milestone survival showed strong surrogacy for OS in second‐line NSCLC trials. Although no association was identified between PFS and OS, the strong HRPFS‐HROS correlation in immunotherapy trials indicates the potential of PFS as a SE in NSCLC trials involving immunotherapies.

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“…In fact, a number of different compounds were used to treat our patients, shown in Table 2. Furthermore, ramucirumab has been approved for the second-line treatment of metastatic NSCLC in combination with docetaxel [34,35], and would therefore be more effective than docetaxel monotherapy as a second-line chemotherapy, except when contraindicated. Recent studies have shown that, after platinum-based chemotherapy failure in patients with NSCLC, monoclonal antibodies against programmed cell death 1 (PD-1) or PD ligand (PD-L1) demonstrate superior OS when compared with standard chemotherapy [36,37,38,39].…”

Section: Discussionmentioning

confidence: 99%

Post-Progression Survival Associated with Overall Survival in Patients with Advanced Non-Small-Cell Lung Cancer Receiving Docetaxel Monotherapy as Second-Line Chemotherapy

Kotake

Miura²,

Imai³

et al. 2017

Chemotherapy

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Background: In patients with non-small-cell lung cancer (NSCLC), the effects of second-line chemotherapy on overall survival (OS) might be confounded by subsequent therapies. Therefore, using individual-level data, we aimed to determine the relationships between progression-free survival (PFS) and post-progression survival (PPS) with OS in patients with advanced NSCLC treated with docetaxel monotherapy as second-line chemotherapy. Methods: Between April 2002 and December 2014, data from 86 patients with advanced NSCLC who underwent second-line docetaxel monotherapy following first-line treatment with platinum combination chemotherapy were analyzed. The relationships of PFS and PPS with OS were analyzed at the individual level. Results: Spearman rank correlation and linear regression analyses showed that PPS was strongly associated with OS (r = 0.86, p < 0.05, R² = 0.93), whereas PFS was moderately correlated with OS (r = 0.50, p < 0.05, R² = 0.21). Performance status at the end of second-line treatment and the number of regimens after progression beyond second-line chemotherapy were significantly associated with PPS (p < 0.05). Conclusions: In patients with advanced NSCLC with unknown oncogenic driver mutations undergoing docetaxel monotherapy as second-line chemotherapy, when compared with PFS, PPS had a stronger association with OS. This finding suggests that subsequent treatment after disease progression following second-line docetaxel monotherapy has a significant influence on OS.

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A randomized, double-blind, phase II study of ramucirumab plus docetaxel vs placebo plus docetaxel in Japanese patients with stage IV non-small cell lung cancer after disease progression on platinum-based therapy

Abstract: Second-line ramucirumab-docetaxel improved PFS similar to that seen in the REVEL trial with a manageable safety profile in Japanese patients with NSCLC.

Cited by 96 publications

References 16 publications

Clinical significance of primary prophylactic pegylated‐granulocyte‐colony stimulating factor after the administration of ramucirumab plus docetaxel in patients with previously treated non‐small cell lung cancer

Clinical significance of primary prophylactic pegylated‐granulocyte‐colony stimulating factor after the administration of ramucirumab plus docetaxel in patients with previously treated non‐small cell lung cancer

Progression‐free survival and one‐year milestone survival as surrogates for overall survival in previously treated advanced non‐small cell lung cancer

Post-Progression Survival Associated with Overall Survival in Patients with Advanced Non-Small-Cell Lung Cancer Receiving Docetaxel Monotherapy as Second-Line Chemotherapy

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