Safety and Effectiveness of Gemcitabine in 855 Patients with Pancreatic Cancer under Japanese Clinical Practice Based on Post-marketing Surveillance in Japan

Abstract

Objective: When gemcitabine was approved as an anti-cancer drug, there were limited data for Japanese patients treated with gemcitabine. Generally, advanced or metastatic pancreatic cancer patients experience poor prognosis and suffer from debilitating disease-related symptoms. Reports and information on gemcitabine use within a large patient pool will be beneficial to aid physicians. Therefore, this post-marketing surveillance was conducted as a non-interventional, observational study on the use of gemcitabine in a clinical practice setting in Japan. Methods: Patients had no previous treatment with gemcitabine and were diagnosed with pancreatic cancer by an attending physician. Patients were registered between May 2001 and December 2003 in Japan. The patients were treated with gemcitabine. Data such as patient background, treatment details, adverse events, tumor response, serum CA19-9 levels and drug-related symptom improvement were assessed. Results: Of the 890 patients registered for the study, 855 were included in the analysis of gemcitabine for safety. Four hundred and forty-three (51.9%) patients reported drug-related adverse events, with 97 patients (11.4%) experiencing serious adverse events. The incidence of interstitial lung disease was 0.7% (six patients). Six hundred patients were evaluated for tumor response. The overall response rate was 6.0% and the disease control rate was 54.0%. CA19-9 decreased in 63.6% of the 335 evaluable patients, with a !75% decrease seen in 19.4% of the total group. Drug-related symptom improvement was observed in 27.0% of the 686 evaluable patients. Conclusions: This large-scale surveillance could confirm the safety of gemcitabine for Japanese pancreatic cancer patients as well as elucidate the efficacy profile, measured by drug-related symptom improvement, for Japanese pancreatic cancer patients.

Postmarketing surveillance study of erlotinib plus gemcitabine for pancreatic cancer in Japan: POLARIS final analysis

“…This is similar to all grades of ILD events reported in 429 patients (4.3%), grade ≥3 ILD events reported in 257 patients (2.6%), and grade 5 ILD events experienced by 153 patients (1.5%) in the Japanese postmarketing POLARSTAR surveillance study in 9 909 NSCLC patients ( 25 ). A surveillance study in Japanese patients with pancreatic cancer treated with gemcitabine alone ( n = 855) demonstrated an incidence of ILD of 0.7% ( n = 6), suggesting that the combination with erlotinib may result in a higher incidence of ILD ( 27 ). Occurrence of ILD in patients with pancreatic cancer was most common at 10–12 weeks following the start of GE treatment in POLARIS.…”

Neoadjuvant and Adjuvant Treatments for Resectable and Borderline Resectable Pancreatic Ductal Adenocarcinoma: The Current Status of Pancreatic Ductal Adenocarcinoma Treatment in Japan

“…Subsequently, postoperative GEM became the standard regimen for the control group in many phase III trials for R-PDAC (Table 2). 2,[8][9][10][11][12][13][14][15][16] The use of 5-FU+LV therapy was recommended for patients who could not be safely administered with GEM, such as those with a history of interstitial pneumonia 17,18 or hemolytic uremic syndrome 19,20 in the Japanese Clinical Practice Guidelines for Pancreatic Cancer.…”

Drug-Induced Interstitial Lung Disease in Oncology Patients

“…Although dyspnea is often reported within the first hours of infusion, interstitial lung diseases (ILD) are seen in <1.4 %, and there is no reported dose dependency. If an ILD is suspected, the CT findings can be highly variable ranging from NSIP, DAD, to pulmonary edema or HP (Dimopoulou et al 2006;Tamura et al 2013;Ioka et al 2013;Vahid and Marik 2008) (Fig. 4).…”