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      Prospective Study on the Incidence of Bone Metastasis (BM) and Skeletal-Related Events (SREs) in Patients (pts) with Stage IIIB and IV Lung Cancer—CSP-HOR 13

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          Bone metastasis (BM) is a frequent complication in patients with advanced lung cancer and it causes skeletal-related events (SREs). Our study aim is to prospectively investigate the incidence of BM, incidence and types of SRE, and predictive factors of BM and SREs.


          Newly diagnosed, advanced non–small-cell lung cancer (NSCLC) or small-cell lung cancer (SCLC) patients were enrolled into the study. Patients were followed up every 4 weeks to monitor the development of SREs. Treatment for lung cancer was performed at the discretion of the investigator.


          Two hundred seventy-four patients were enrolled in this study between April 2007 and December 2009 from 12 institutions. Patients included 77 cases of SCLC and 197 of NSCLC (stage IIIB/IV = 73/124). Median follow-up time was 13.8 months. The incidence of BM at initial diagnosis was 48% in stage IV NSCLC and 40% in extensive stage (ED)-SCLC. Forty-five percent of patients who developed BM had SREs consisting of pathologic fracture (4.7%), radiation to bone (15.3%), spinal cord compression (1.1%), and hypercalcemia (2.2%). Multivariate analysis revealed that factors predicting BM are stage IV, performance status 1 or greater and higher bone alkaline phosphatase in NSCLC patients, higher lactate dehydrogenase, and lower parathyroid hormone–related peptide in SCLC patients. Factors predicting SREs were stage IV, age 64 or younger, and lower albumin in NSCLC patients. Multivariate analysis of SRE was not performed for SCLC because of the small number of events.


          Predictive factors should be taken into consideration in future randomized studies evaluating BM and SREs.

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          Most cited references 19

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          Irinotecan plus cisplatin compared with etoposide plus cisplatin for extensive small-cell lung cancer.

          Irinotecan hydrochloride, a topoisomerase I inhibitor, is effective against small-cell lung cancer. In a phase 2 study of irinotecan plus cisplatin in patients with extensive small-cell lung cancer, there was a high response rate and a promising median survival time. We conducted a multicenter, randomized, phase 3 study in which we compared irinotecan plus cisplatin with etoposide plus cisplatin in patients with extensive (metastatic) small-cell lung cancer. The planned size of the study population was 230 patients, but enrollment was terminated early because an interim analysis found a statistically significant difference in survival between the patients assigned to receive irinotecan and cisplatin and those assigned to receive etoposide and cisplatin; as a result, only 154 patients were enrolled. The median survival was 12.8 months in the irinotecan-plus-cisplatin group and 9.4 months in the etoposide-plus-cisplatin group (P=0.002 by the unadjusted log-rank test). At two years, the proportion of patients surviving was 19.5 percent in the irinotecan-plus-cisplatin group and 5.2 percent in the etoposide-plus-cisplatin group. Severe or life-threatening myelosuppression was more frequent in the etoposide-plus-cisplatin group than in the irinotecan-plus-cisplatin group, and severe or life-threatening diarrhea was more frequent in the irinotecan-plus-cisplatin group than in the etoposide-plus-cisplatin group. Irinotecan plus cisplatin is an effective treatment for metastatic small-cell lung cancer.
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            Randomized phase III trial comparing irinotecan/cisplatin with etoposide/cisplatin in patients with previously untreated extensive-stage disease small-cell lung cancer.

            Etoposide and cisplatin (EP) has been a standard treatment for extensive-disease small-cell lung cancer (SCLC). An earlier phase III trial reported improved survival for patients receiving irinotecan plus cisplatin (IP) versus EP. Our trial was designed to determine if a modified weekly regimen of IP would provide superior survival with less toxicity than EP. The primary objective was to compare overall survival in extensive-disease SCLC patients randomly assigned to receive IP (n = 221) or EP (n = 110). Patients were randomly assigned in 2:1 ratio to cisplatin 30 mg/m2 intravenously (IV) + irinotecan 65 mg/m2 IV on days 1 and 8 every 21 days, or cisplatin 60 mg/m2 IV on day 1, and etoposide 120 mg/m2 IV on days 1 to 3 every 21 days for at least four cycles, until progressive disease, or until intolerable toxicity resulted. Selected grade 3/4 toxicities for IP/EP were: neutropenia (36.2% v 86.5%; P < .01), febrile neutropenia (3.7% v 10.4%; P = .06), anemia (4.8% v 11.5%; P = .02), thrombocytopenia (4.3% v 19.2%; P < .01), vomiting (12.5% v 3.8%; P = .04), and diarrhea (21.3% v 0%; P < .01). There was no significant difference in response rates (48% v 43.6%), median time to progression (4.1 v 4.6 months), or overall survival (median survival time, 9.3 months v 10.2 months; P = .74). Treatment with this dose and schedule of IP did not result in improved survival when compared with EP. Fewer patients receiving IP had grade 3/4 anemia, thrombocytopenia, neutropenia, and febrile neutropenia compared with patients receiving EP, but more had grade 3/4 diarrhea and vomiting.
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              Skeletal metastases in non-small cell lung cancer: a retrospective study.

              The skeleton is one of the most common sites of metastasis in patients with advanced cancer. Bone metastases often cause SREs (skeletal-related events). Despite advances in the treatment of primary lung cancer, SREs still affect many patients. Therefore, we planned a retrospective study to investigate the clinical impact of SREs, and to compare differences in the therapeutic outcome between patients with and without skeletal metastases or SRE. We retrospectively investigated the charts of all 259 patients with non-small cell lung cancer (NSCLC) who consulted the Department of Medical Oncology at Kinki University School of Medicine between February 2002 and January 2005. We assessed their TNM stage, presence of skeletal metastases (on bone scintigraphy, MRI, and plain X-ray films), and outcome parameters such as SREs, analgesic use, and survival. A total of 70 patients (30.4%) were found to have skeletal metastases during their clinical course and 35 patients (50%) out of all 70 patients had SREs. Among 135 stage IV patients, a total of 56 (41%) had skeletal metastases, and 25 of these 56 patients (45%) had SREs. The most common SREs were the need for radiotherapy (34.3%) and hypercalcemia (20%). Patients with SREs tended to have worse survival, while no significant difference of survival was observed between patients with and without skeletal metastases. It seems to be important to prevent SREs during the treatment of NSCLC, so further studies evaluating bisphosphonates in combination with chemotherapy are warranted.

                Author and article information

                J Thorac Oncol
                J Thorac Oncol
                Journal of Thoracic Oncology
                Lippincott Williams & Wilkins
                February 2014
                23 January 2014
                : 9
                : 2
                : 231-238
                [* ]Institute of Biomedical Research and Innovation, Kobe, Japan; []Yokohama Municipal Citizen’s Hospital, Yokohama, Japan; []Osaka City General Hospital, Osaka, Japan; [§ ]Kyushu University Hospital, Fukuoka, Japan; []Gifu Municipal Hospital, Gifu, Japan; []Aichi Cancer Center Aichi Hospital, Okazaki, Japan; [# ]National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan; [** ]Toneyama National Hospital, Toyonaka, Japan; [†† ]Tokai University School of Medicine, University Hospital, Isehara, Japan; [‡‡ ]Shizuoka Cancer Center, Shizuoka, Japan; [§§ ]The University of Tokyo, Tokyo, Japan; and [‖‖ ]Teikyo University School of Medicine, Tokyo, Japan.
                Author notes
                Address for correspondence: Nobuyuki Katakami, MD, PhD, Institute of Biomedical Research and Innovation, 2-2 Minatojima Minamimachi, Chuo-ku, Kobe, 650-0047, Japan. E-mail: nkatakami@ 123456kcho.jp
                Copyright © 2013 by the International Association for the Study of Lung Cancer

                This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivitives 3.0 License, where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially.

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