A phase II study of carboplatin plus weekly paclitaxel with bevacizumab for elderly patients with non-squamous non-small-cell lung cancer (NEJ016).
Background The efficacy and safety of bevacizumab in elderly patients with non-small cell lung cancer remain controversial. This study focused on both selecting fit elderly patients and overcoming interpatient variability with respect to pharmacodynamics. Methods Elderly (age: ≥70 years) patients with advanced non-squamous non-small cell lung cancer were enrolled. Patients with uncontrolled congestive heart failure and uncontrolled diabetes were excluded. The treatment regimen comprised carboplatin at an area under the curve of 5 mg/ml/min on day 1, paclitaxel at 90 mg/m2on days 1 and 8, and bevacizumab at 15 mg/kg on day 1 every 21 days for up to 4 cycles, followed by maintenance bevacizumab. Dose reduction due to side effects was performed, with a wide range of doses of paclitaxel from 23 mg/m2/week to 60 mg/m2/week. Results Of the 36 patients entered, 38.9% required a dose reduction or cancellation of paclitaxel administration on day 8, and 75% patients were able to complete 4 cycles of triplet therapy. The response rate, primary endpoint, was 69.4% (95% confidence interval [CI]: 51.9-83.7). The median progression free survival and overall survival were 8.4 months and 29.2 months, respectively. The most common adverse events included neutropenia, hypertension, anemia, and infection. Although Grade ≥ 3 adverse events were observed in 24 patients (66.7%), there were no deaths due to toxicity. Conclusion Carboplatin plus weekly paclitaxel with bevacizumab is a feasible, effective first-line regimen for elderly non-small cell lung cancer patients. (UMIN00006622).
Department of Internal Medicine, Niigata Cancer Center Hospital, 2-15-3, Kawagishicho, Chuo-ku, Niigata, 951-8566, Japan. miusat1118@niigata-cc.jp.|Department of Respiratory Medicine and Infectious Disease, Niigata University Medical and Dental Hospital, Niigata, Japan. miusat1118@niigata-cc.jp.
Satoru
0000-0001-7868-6661
S
Miura
Department of Respiratory Medicine, Miyagi Cancer Center, Natori, Japan.
Makoto
M
Maemondo
Department of Respiratory Medicine, Nagaoka Chuo General Hospital, Nagaoka, Japan.
Akira
A
Iwashima
Center for Respiratory Diseases, Japan Community Health Care Organization Hokkaido Hospital, Sapporo, Japan.
Toshiyuki
T
Harada
Department of Pulmonary Medicine, Sendai Kousei Hospital, Sendai, Japan.
Shunichi
S
Sugawara
Department of Respiratory Medicine, Saitama Medical University International Medical Center, Hidaka, Japan.
Kunihiko
K
Kobayashi
Department of Palliative Medicine, Tohoku University School of Medicine, Sendai, Japan.
Akira
A
Inoue
Department of Thoracic Surgery, Omagari Kosei Medical Center, Akita, Japan.
Taku
T
Nakagawa
Department of Medical Oncology, Graduate School of Medicine, Chiba University, Chiba, Japan.
Yuichi
Y
Takiguchi
Department of Respiratory Medicine, Saka General Hospital, Shiogama, Japan.
Hiroshi
H
Watanabe
Department of Internal Medicine, Niigata Prefectural Central Hospital, Joetsu, Japan.
Takashi
T
Ishida
Department of Respiratory Medicine, Saiseikai Niigata Daini Hospital, Niigata, Japan.
Masaki
M
Terada
Department of Respiratory Medicine and Infectious Disease, Niigata University Medical and Dental Hospital, Niigata, Japan.|Department of Respiratory Medicine, Saitama Medical University International Medical Center, Hidaka, Japan.
Hiroshi
H
Kagamu
Department of Pulmonary Medicine and Oncology, Nippon Medical School, Graduate School of Medicine, Tokyo, Japan.
Akihiko
A
Gemma
Department of Respiratory Medicine and Infectious Disease, Niigata University Medical and Dental Hospital, Niigata, Japan.|Department of Respiratory Medicine, Niigata Medical Center Hospital, Niigata, Japan.
Hirohisa
H
Yoshizawa
D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000068258:Bevacizumab / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D000068258:Bevacizumab; D016190:Carboplatin; D017239:Paclitaxel
Bevacizumab; Elderly patients; Non-small cell lung cancer; Non-squamous histology; Patient selection