| Title |
Phase I/II study of docetaxel combined with resminostat, an oral hydroxamic acid HDAC inhibitor, for advanced non-small cell lung cancer in patients previously treated with platinum-based chemotherapy
|
|---|---|
| Published in |
Investigational New Drugs, January 2017
|
| DOI | 10.1007/s10637-017-0435-2 |
| Pubmed ID | |
| Authors |
Yuichi Tambo, Yukio Hosomi, Hiroshi Sakai, Naoyuki Nogami, Shinji Atagi, Yasutsuna Sasaki, Terufumi Kato, Toshiaki Takahashi, Takashi Seto, Makoto Maemondo, Hiroshi Nokihara, Ryo Koyama, Kazuhiko Nakagawa, Tomoya Kawaguchi, Yuta Okamura, Osamu Nakamura, Makoto Nishio, Tomohide Tamura |
| Abstract |
Objectives To determine the recommended dose and efficacy/safety of docetaxel combined with resminostat (DR) in non-small cell lung cancer (NSCLC) patients with previous platinum-based chemotherapy. Materials and Methods A multicenter, open-label, phase I/II study was performed in Japanese patients with stage IIIB/IV or recurrent NSCLC and prior platinum-based chemotherapy. The recommended phase II dose was determined using a standard 3 + 3 dose design in phase I part. Resminostat was escalated from 400 to 600 mg/day and docetaxel fixed at 75 mg/m(2). In phase II part, the patients were randomly assigned to docetaxel alone (75 mg/m(2)) or DR therapy. Docetaxel was administered on day 1 and resminostat on days 1-5 in the DR group. Treatment was repeated every 21 days until progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS). Results A total of 117 patients (phase I part, 9; phase II part, 108) were enrolled. There was no dose-limiting toxicity in phase I part; the recommended dose for resminostat was 600 mg/day with 75 mg/m(2) of docetaxel. In phase II part, median PFS (95% confidence interval [CI]) was 4.2 (2.8-5.7) months with docetaxel group and 4.1 (1.5-5.4) months with DR group (hazard ratio [HR]: 1.354, 95% CI: 0.835-2.195; p = 0.209). Grade ≥ 3 adverse events significantly more common with DR group than docetaxel group were leukopenia, febrile neutropenia, thrombocytopenia, and anorexia. Conclusion In Japanese NSCLC patients previously treated with platinum-based chemotherapy, DR therapy did not improve PFS compared with docetaxel alone and increased toxicity. |
Mendeley readers
The data shown below were compiled from readership statistics for 42 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 42 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Student > Master | 8 | 19% |
| Researcher | 7 | 17% |
| Student > Bachelor | 4 | 10% |
| Student > Doctoral Student | 4 | 10% |
| Student > Postgraduate | 2 | 5% |
| Other | 8 | 19% |
| Unknown | 9 | 21% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 13 | 31% |
| Biochemistry, Genetics and Molecular Biology | 7 | 17% |
| Nursing and Health Professions | 4 | 10% |
| Pharmacology, Toxicology and Pharmaceutical Science | 3 | 7% |
| Unspecified | 1 | 2% |
| Other | 5 | 12% |
| Unknown | 9 | 21% |
Attention Score in Context
This research output has an Altmetric Attention Score of 3. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 19 October 2017.
All research outputs
#7,531,132
of 22,979,862 outputs
Outputs from Investigational New Drugs
#327
of 1,173 outputs
Outputs of similar age
#143,927
of 420,179 outputs
Outputs of similar age from Investigational New Drugs
#10
of 21 outputs
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We're also able to compare this research output to 21 others from the same source and published within six weeks on either side of this one. This one is in the 38th percentile – i.e., 38% of its contemporaries scored the same or lower than it.