Evaluation of α-1-acid glycoprotein as a prognostic factor of survival in patients with stage II-III esophageal carcinoma treated with neoadjuvant docetaxel, cisplatin, and fluorouracil chemotherapy followed by surgery.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 100-100 ◽  
Author(s):  
Yusuke Sasaki ◽  
Ken Kato ◽  
Koh Furuta ◽  
Naoki Takahashi ◽  
Hirokazu Shoji ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Prognostic Factor ◽  
Response Rate ◽  
Tnm Classification ◽  
Clinical Stage ◽  
Progression Free Survival ◽  
Hazard Ratio ◽  
Stage Ii ◽  
R0 Resection ◽  
Acid Glycoprotein

100 Background: Serum α-1-acid glycoprotein (AAG) level was an independent predictor of response and a prognostic factor of survival in patients with non-small cell lung cancer treated with docetaxel chemotherapy. However, it has not been determined whether AAG is associated with the outcomes of esophageal cancer patients who have been treated with a combination of docetaxel, cisplatin and 5-fluorouracil (DCF) as neoadjuvant therapy. Methods: This retrospective study included a cohort of 39 patients with clinical stage II/III esophageal cancer, based on the International Union Against Cancer TNM classification system 7th edition, who were treated with neoadjuvant DCF followed by surgery. DCF consisted of docetaxel (70mg/m2) and cisplatin (70mg/m2) on day 1, and continuous infusion of 5-fluorouracil (750mg/m2/day) on days 1-5, with this regimen repeated every 3 weeks up to three cycles. Patients were divided into groups by median value of baseline AAG levels. Patient characteristics, preoperative clinical stage, chemotherapy effect, and survival were compared between the high and low AAG groups. Results: The clinical stage IIA, IIB, IIIA, IIIB and IIIC were 4, 4, 14, 17 and 0, respectively. The completion rate of three cycles of chemotherapy was 76.9% (30/39). All patients underwent surgery and the R0 resection rate was 97.4% (38/39). The best overall response rate of DCF was 48.7% with a pathological complete response of 5.1%. The 2-year progression-free survival and overall survival (OS) rates were 60.5% and 76.9%, respectively. The median serum AAG was 95 g/L, ranging from 57 to 228 g/L. A trend of lower response rate (35.0% vs. 57.9%; P = 0.20) and shorter OS (median not reached; hazard ratio [HR] 2.08; P = 0.24) was observed in patients with a high AAG level (AAG > 95 g/L) compared with a low AAG level (AAG ≦ 95 g/L). Multivariate analysis showed an AAG level hazard ratio of 1.60 (P = 0.59) for OS. Conclusions: There was a trend toward improved response and survival with low serum AAG level, for patients with esophageal cancer who received neoadjuvant DCF chemotherapy.

Retrospective analysis of neoadjuvant chemoradiotherapy for esophageal cancer: The Knight Cancer Institute experience.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 126-126
Author(s):  
Faisal A Siddiqui ◽  
James P. Dolan ◽  
John G. Hunter ◽  
Miriam A. Douthit ◽  
Lisa M. Bloker ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Complete Remission ◽  
Early Stage ◽  
Clinical Stage ◽  
Pathologic Complete Response ◽  
Neoadjuvant Chemoradiotherapy ◽  
Stage Ii ◽  
R0 Resection ◽  
Trimodality Therapy ◽  
Initial Staging

126 Background: Neoadjuvant chemoradiotherapy (NAT) followed by esophagectomy has been established as standard of care for early stage (II – III), resectable esophageal cancer (EC). Patients (pts) treated with NAT are more likely to be downstaged and have a complete (R0) resection. Additionally, pts with aggressive disease are more likely to progress during NAT and, consequently, avoid unnecessary surgery. The aim of the current report was to analyze the outcomes of trimodality therapy at the Knight Cancer Institute. Methods: A retrospective study of 124 pts who underwent NAT followed by esophagectomy for EC from 1999-2010 at our institution was performed. All pts were initially staged by imaging (EUS, CT and/or PET imaging) prior to commencing treatment. After esophagectomy, pathological staging was compared to initial staging to determine the effect of NAT. Results: There were 25 women and 99 men. Initial staging is shown in the table below. Patients received cisplatin, oxaliplatin or carboplatin with 5-FU plus concurrent radiotherapy (RT). RT total dose of 45 Gy to the tumor and regional nodes was given in 1.8 Gy daily fractions, followed by a boost to the tumor for final dose 50.4-54 Gy. 27 (21.8%) of the pts had a pathologic complete response. Additionally, 54 (43.6%) pts were downstaged by chemoradiation. Of the pts that had complete remission or were downstaged, pre-treatment clinical stage was Stage II (22 pts), Stage III (55 pts), and Stage IVa (4 pts). Conclusions: NAT was effective in complete remission or downstaging of two-thirds (81) pts, including 4 pts that were initially unresectable (Stage IVa) and successfully underwent subsequent esophagectomy. As has been shown previously, NAT is effective for downstaging prior to esophagectomy making it more likely that pts will undergo R0 resection. This study also demonstrated that some pts with clinically unresectable tumors could undergo successful esophagectomy after NAT. [Table: see text]

Changes in modified Glasgow prognostic score after neoadjuvant chemotherapy is a prognostic factor in clinical stage II/III esophageal cancer

2016 ◽  
Vol 29 (2) ◽  
pp. 146-151 ◽  
Author(s):  
Yasunori Otowa ◽  
Tetsu Nakamura ◽  
Gosuke Takiguchi ◽  
Ayako Tomono ◽  
Masashi Yamamoto ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Prognostic Factor ◽  
Neoadjuvant Chemotherapy ◽  
Squamous Cell ◽  
Prognostic Score ◽  
Clinical Stage ◽  
Glasgow Prognostic Score ◽  
Serum Levels ◽  
Stage Ii ◽  
Modified Glasgow Prognostic Score

Summary The inflammation-based modified Glasgow prognostic score (mGPS) has been shown to be a prognostic factor for esophageal cancer, but its changes in relation to neoadjuvant chemotherapy (NAC) have never been discussed. The purpose of this study was to evaluate the potential prognostic role of mGPS with regard to NAC. mGPS was evaluated on the basis of admission blood samples taken before chemotherapy and before surgery. Patients with elevated C-reactive protein (CRP) serum levels (>10 mg/L) and hypoalbuminemia (<35 g/L) were allocated a score of 2, patients with elevated CRP serum levels without hypoalbuminemia were allocated a score of 1, and patients with normal CRP serum levels with or without hypoalbuminemia were allocated a score of 0. A total of 100 patients with clinical stage II/III squamous cell esophageal cancer, who underwent NAC and esophagectomy between January 2007 and August 2012, were investigated. From the multivariate analysis, the grade of response to chemotherapy and post-NAC mGPS level was found to be independent prognostic factors. The overall survival rate was significantly higher in the conserved mGPS group than in the worse mGPS group (P = 0.030). Changes in mGPS during chemotherapy affected the prognosis of patients, and post-NAC mGPS is an independent prognostic factor in patients with clinical stage II/III thoracic esophageal squamous cell cancer.

Mantle Irradiation Alone for Clinical Stage I-II Hodgkin's Disease: Long-Term Follow-Up and Analysis of Prognostic Factors in 261 Patients

1999 ◽  
Vol 17 (1) ◽  
pp. 230-230 ◽  
Author(s):  
A. Wirth ◽  
M. Chao ◽  
J. Corry ◽  
C. Laidlaw ◽  
K. Yuen ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
Prognostic Factor ◽  
Hodgkin's Disease ◽  
Hodgkin’S Disease ◽  
Clinical Stage ◽  
Progression Free Survival ◽  
Stage I ◽  
Stage Ii ◽  
Multifactor Analysis

PURPOSE: To evaluate mantle radiotherapy (MRT) alone as the initial therapy of patients with clinical stage (CS) I-II Hodgkin's disease (HD). PATIENTS AND METHODS: We performed a retrospective study of patients treated with MRT alone for CS I-II supradiaphragmatic HD between 1969 and 1994. Prognostic factor analysis was performed for progression-free survival (PFS) and overall survival (OS). Outcome was also assessed in favorable cohorts defined in the literature. RESULTS: There were 261 eligible patients. The median follow-up period for surviving patients was 8.4 years (range, 1.8 to 27.4 years). The 10-year OS rate was 73%. Multifactor analysis for OS showed that age was the only important prognostic factor. The 10-year PFS rate was 58%. On multifactor analysis for PFS, the most important prognostic factors were clinical stage, B symptoms, histology, number of sites, and tumor bulk. The 10-year PFS rate for lymphocyte-predominant disease was 81% for stage I and 78% for stage II. In favorable patient cohorts defined in the literature, the 10-year PFS rate ranged from 70% to 73% for the whole group and from 71% to 90% in patients with favorable stage I disease, but only from 48% to 57% in patients with favorable stage II disease. On competing-risks analysis, the cumulative 10-year incidence of first site of failure in the para-aortic/splenic region alone was 10.5%. Sixty percent of relapsed patients remain progression-free at 10 years after chemotherapy salvage. CONCLUSION: These results support the use of MRT alone in patients with favorable CS I HD and CS I-II HD with lymphocyte-predominant histology. The remainder of patients with CS I-II HD require more intensive treatment.

PS02.116: FEASIBILITY OF DOCETAXEL, CISPLATIN, AND 5-FLUOROURACIL (DCF) VERSUS RADIOTHERAPY WITH DCF (DCF-RT) AS PREOPERATIVE THERAPY FOR LOCALLY ADVANCED ESOPHAGEAL CANCER

2018 ◽  
Vol 31 (Supplement_1) ◽  
pp. 154-154
Author(s):  
Shoji Natsugoe ◽  
Ken Sasaki ◽  
Yasuto Uchikado ◽  
Hiroshi Okumura ◽  
Itaru Omoto ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Response Rate ◽  
Radical Surgery ◽  
Clinical Stage ◽  
Locally Advanced ◽  
Pathologic Complete Response ◽  
Preoperative Chemoradiotherapy ◽  
Stage Ii ◽  
Advanced Esophageal Cancer ◽  
Locally Advanced Esophageal Cancer

Abstract Background In Japan, preoperative chemotherapy with cisplatin plus 5-fluorouracil (CF) followed by radical surgery has been accepted as the standard therapeutic approach for resectable esophageal squamous cell carcinoma (ESCC) result from a Japan Clinical Oncology Group randomized control trial. Whether preoperative chemoradiotherapy (CRT) followed by radical surgery is effective for Japanese ESCC patients has yet to be established. Some trials have reported usefulness of CF plus docetaxel therapy (DCF) for advanced or metastatic ESCC. Here, we have launched a randomized controlled trial to compare preoperative DCF versus DCF plus radiotherapy (DCF-RT) followed by surgery in locally advanced esophageal cancer. Methods Patients with clinical stage II/III (Japanese Classification of Esophageal Cancer, 11th Edition) are randomized to 2 groups. Patients in DCF group receive 2 courses of preoperative DCF (docetaxel, 60 mg/m2/day, day 1; cisplatin, 70 mg/m2/day, day 1; 5-FU, 700 mg/m2/day, days 1–5) repeated every 3 weeks. Patients in DCF-RT group receive preoperative chemoradiotherapy (40Gy/20fr) with 2 courses of DCF (docetaxel, 30 mg/m2/day, day 1, 15; cisplatin, 7 mg/m2/day and 5-FU, 350 mg/m2/day, days 1–5, days 8–12, days 15–19, days 22–26). The primary endpoint is overall survival and the secondary endpoints include adverse events, response rate and pathologic complete response rate. Results Twenty-seven patients were assigned to the DCF group and 26 patients to the DCF-RT group. Grade 3/4 leukopenia and febrile neutropenia occurred 37% and 19% in the DCF group, 35% and 12% in the DCF-RT group. The clinical response rates were 16.0% and 64.0% in the DCF and DCF-RT group. Twenty patients and 23 patients underwent surgery in the DCF and DCF-RT group, and the R0 resection rate was 80.0% and 91.3%. With regard to the surgical complications, the incidence of anastomotic leakage was significantly higher in the DCF-RT group compared with the DCF group. The histological effects of DCF-RT were significantly higher than those of DCF. Two-year survival rate was 46% in the DCF group and 70% in the DCF-RT group. Conclusion The DCF and DCF-RT were found to be feasible as neoadjuvant therapy, and DCF-RT demonstrated higher efficacy than DCF in clinical stage II/III esophageal cancer patients. Disclosure All authors have declared no conflicts of interest.

A phase II trial of definitive chemoradiotherapy with docetaxel, cisplatin, and 5-fluorouracil (DCF-R) in advanced esophageal cancer (KDOG 0501-P2).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 4070-4070
Author(s):  
Katsuhiko Higuchi ◽  
Shouko Komori ◽  
Satoshi Tanabe ◽  
Chikatoshi Katada ◽  
Mizutomo Azuma ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Phase Ii ◽  
Response Rate ◽  
Tnm Classification ◽  
Progression Free Survival ◽  
Late Toxicity ◽  
Thoracic Esophagus ◽  
Advanced Esophageal Cancer ◽  
Definitive Chemoradiotherapy ◽  
Grade 3

4070 Background: Our previous phase I study (Radiother Oncol 2008,87:398) provided evidence that definitive chemoradiotherapy with docetaxel, cisplatin, and 5-fluorouracil (DCF-R) was tolerable and active in patients with advanced esophageal cancer (AEC). This phase II study was conducted to confirm the efficacy and toxicity of DCF-R in AEC. Methods: Patients with previously untreated carcinoma of the thoracic esophagus who had T4 tumors, M1 lymph-node metastasis, or both received an infusion of docetaxel (35 mg/m2) and an infusion of cisplatin (40 mg/m2) on day 1 and a continuous infusion of 5-fluorouracil (400mg/m2/day) on days 1-5, every 2 weeks, plus concurrent radiation (RT). The total RT dose was initially 61.2, but was lowered to multiple-field irradiation with 50.4 Gy to decrease esophagitis and late toxicity. Consequently, the number of cycles of DCF administered during RT was modified from 4 to 3. After DCF-R, patients received at least 2 cycles of DCF (docetaxel 40 mg/m2 on day 1, cisplatin 60 mg/m2 on day 1, and 5-fluorouracil 600 mg/m2on days 1-5, every 4 weeks). The primary endpoint was the clinical complete response rate (cCRR). Secondary endpoints were response rate (RR), progression free survival (PFS), overall survival, and safety. Results: 42 patients (36 men, 6 women) were enrolled. The median age was 62 years (range: 46-75). PS 0/1/2 was 14/25/3. TNM classification T4M0/non-T4M1LYM/T4M1LYM was 20/12/10. The total scheduled dose of RT 61.2Gy /50.4Gy was 12/30 patients. The RR was 90.5% and the cCRR was 52.4% (95% CI:37.3-67.5%). As of January 2013, the median PFS was 11.1 months and the median survival time was 23.1 months. Grade 3 or higher major toxicities comprised leukopenia (71.4%), neutropenia (57.2%), anemia (16.7%), febrile neutropenia (38.1%), anorexia (31.0%), and esophagitis (28.6%). There was one treatment-related death caused by aspiration pneumonia. Grade 3 or higher late toxicities comprised one pericardial effusion (Grade 4), one case of esophagitis (Grade 3), and one case of thoracic aortic aneurysm (Grade 3). Conclusions: DCF-R frequently caused myelosuppression, but was highly active and suggested be a promising regimen in AEC. Clinical trial information: 000002029.

FRONTiER: A feasibility trial of nivolumab with neoadjuvant CF or DCF therapy for locally advanced esophageal carcinoma (JCOG1804E)—The short-term results of cohort A and B.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 202-202
Author(s):  
Shun Yamamoto ◽  
Ken Kato ◽  
Hiroyuki Daiko ◽  
Takashi Kojima ◽  
Hiroki Hara ◽  
...  
Keyword(s):  
Adverse Events ◽  
Checkpoint Inhibitors ◽  
Tnm Classification ◽  
Clinical Stage ◽  
Cell Cancer ◽  
Locally Advanced ◽  
Cytotoxic Agents ◽  
Feasibility Trial ◽  
R0 Resection ◽  
Breast Cancers

202 Background: The standard neoadjuvant chemotherapy (NAC) in Japan for locally advanced esophageal squamous cell cancer (ESCC) is CDDP + 5-FU (CF). Immune checkpoint inhibitors (ICI) such as nivolumab provide a survival benefit in ESCC, and have potential as NAC agents in lung, skin, and breast cancers, amongst others. However, whether ICI are efficacious in combination with cytotoxic agents, and whether ICI impact the safety of subsequent surgery after they are used as NAC for ESCC patients (pts) is currently unclear. Methods: FRONTiER is a multi-cohort phase I study designed to evaluate the safety and efficacy of ICI combined with NAC in ESCC. Histologically proven ESCC pts with cT1N1-3M0 or cT2-3N0-3M0 (8th-UICC TNM classification), 20–75 years old, PS ≤ 1, no prior therapies against any cancer were eligible. The primary endpoint was the incidence of dose-limiting toxicities (DLT) from the initial dose to the 30th postoperative day. This study contained 4 experimental cohorts, the NAC regimen of cohort A consisted of 2 courses of CDDP at 80 mg/m2, nivolumab at 360 mg/body on day 1 and 5-FU at 800 mg/m2 on days 1–5, q3wks. The regimen of cohort B consisted of one administration of nivolumab at 240 mg/body 2 weeks before chemotherapy, followed by the same treatments as cohort A. Results: Thirteen pts were enrolled to cohort A (n = 6) and B (n = 7). Characteristics were follows; median age: 62 (range: 34–75), PS 0/1: 9/4 pts, clinical stage I/II/III: 2/1/10 pts. One pt in cohort B was excluded from safety evaluation due to R2 resection, no DLTs were observed in 12 pts. The most frequent adverse events (≥ grade 3) were neutropenia in 6 pts during NAC, lung infection in 1, hyperglycemia in 1, pleural effusion in 1, infection (right neck) in 1, anemia in 1, abdominal pain in 1, and anatomic leakage in 1 during the postoperative period. Within 30 days post-operation, grade 2 adrenal insufficiency was observed in 1 pt of cohort B. No grade 4 adverse events or treatment-related deaths were seen. All pts received two courses of NAC + nivolumab and R0 resection was achieved in 12 pts (92.3%) without interruption of treatment. A pathological complete response was achieved in 2 pts (33.3%) in cohort A. Conclusions: Neoadjuvant CF + nivolumab with/without prior administration of nivolumab followed by surgery for locally advanced ESCC was well tolerated and showed promising efficacy. Clinical trial information: NCT03914443.

scholarly journals Loss of Chromosome 18q11.2-q12.1 Is Predictive for Survival in Patients With Metastatic Colorectal Cancer Treated With Bevacizumab

2018 ◽  
Vol 36 (20) ◽  
pp. 2052-2060 ◽  
Author(s):  
Erik van Dijk ◽  
Hedde D. Biesma ◽  
Martijn Cordes ◽  
Dominiek Smeets ◽  
Maarten Neerincx ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Multicenter Study ◽  
Overall Response Rate ◽  
Response Rate ◽  
Progression Free Survival ◽  
Hazard Ratio ◽  
Tumor Biopsy ◽  
Overall Response ◽  
European Multicenter Study

Purpose Patients with metastatic colorectal cancer (mCRC) have limited benefit from the addition of bevacizumab to standard chemotherapy. However, a subset probably benefits substantially, highlighting an unmet clinical need for a biomarker of response to bevacizumab. Previously, we demonstrated that losses of chromosomes 5q34, 17q12, and 18q11.2-q12.1 had a significant correlation with progression-free survival (PFS) in patients with mCRC treated with bevacizumab in the CAIRO2 clinical trial but not in patients who did not receive bevacizumab in the CAIRO trial. This study was designed to validate these findings. Materials and Methods Primary mCRC samples were analyzed from two cohorts of patients who received bevacizumab as first-line treatment; 96 samples from the European multicenter study Angiopredict (APD) and 81 samples from the Italian multicenter study, MOMA. A third cohort of 90 samples from patients with mCRC who did not receive bevacizumab was analyzed. Copy number aberrations of tumor biopsy specimens were measured by shallow whole-genome sequencing and were correlated with PFS, overall survival (OS), and response. Results Loss of chromosome 18q11.2-q12.1 was associated with prolonged PFS most significantly in both the cohorts that received bevacizumab (APD: hazard ratio, 0.54; P = .01; PFS difference, 65 days; MOMA: hazard ratio, 0.55; P = .019; PFS difference, 49 days). A similar association was found for OS and overall response rate in these two cohorts, which became significant when combined with the CAIRO2 cohort. Median PFS in the cohort of patients with mCRC who did not receive bevacizumab and in the CAIRO cohort was similar to that of the APD, MOMA, and CAIRO2 patients without an 18q11.2-q12.1 loss. Conclusion We conclude that the loss of chromosome 18q11.2-q12.1 is consistently predictive for prolonged PFS in patients receiving bevacizumab. The predictive value of this loss is substantiated by a significant gain in OS and overall response rate.

scholarly journals Conversion Chemotherapy With a Modified FLOX Regimen for Borderline or Unresectable Liver Metastases From Colorectal Cancer: An Alternative for Limited-Resources Settings

2019 ◽  
pp. 1-6
Author(s):  
Renata Colombo Bonadio ◽  
Paulo Henrique Amor Divino ◽  
Jorge Santiago Madero Obando ◽  
Karolina Cayres Alvino Lima ◽  
Débora Zachello Recchimuzzi ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Liver Metastases ◽  
Median Overall Survival ◽  
Low Cost ◽  
Progression Free Survival ◽  
Hazard Ratio ◽  
R0 Resection ◽  
Free Survival ◽  
Unresectable Liver Metastases

PURPOSE Conversion chemotherapy is often used for borderline or unresectable (B/U) liver metastases from colorectal cancer (CRC) with the aim of achieving resectability. Although intensive and costly regimens are often used, the best regimen in this scenario remains unclear. We aimed to evaluate the outcomes of patients with B/U liver metastases from CRC treated with conversion chemotherapy with the modified fluorouracil, leucovorin, and oxaliplatin (mFLOX) regimen followed by metastasectomy. METHODS We performed a single-center retrospective analysis of patients with B/U liver metastases from CRC treated with chemotherapy with the mFLOX regimen followed by surgery. B/U disease was defined as at least one of the following: more than four lesions, involvement of hepatic artery or portal vein, or involvement of biliary structure. RESULTS Fifty-four consecutive patients who met our criteria for B/U liver metastases were evaluated. Thirty-five patients (64%) had more than four liver lesions, 16 (29%) had key vascular structure involvement, and 16 (29%) had biliary involvement. After chemotherapy, all patients had surgery and 42 (77%) had R0 resection. After a median follow-up of 37.2 months, median progression-free survival (PFS) was 16.9 months and median overall survival (OS) was 68.3 months. R1-R2 resections were associated with worse PFS and OS compared with R0 resection (PFS: hazard ratio, 2.65; P = .007; OS: hazard ratio, 2.90; P = .014). CONCLUSION Treatment of B/U liver metastases from CRC with conversion chemotherapy using mFLOX regimen followed by surgical resection was associated with a high R0 resection rate and favorable survival outcomes. On the basis of our results, we consider mFLOX a low-cost option for conversion chemotherapy among other options that have been proposed.

Retrospective analysis of gefitinib versus docetaxel in never-smoking patients with previously treated non-small-cell lung cancer (NSCLC)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 17154-17154
Author(s):  
Y. Kogure ◽  
S. Ueda ◽  
Y. Nakamura ◽  
M. Ebisawa ◽  
G. Asai ◽  
...  
Keyword(s):  
Multivariate Analysis ◽  
Response Rate ◽  
Performance Status ◽  
Progression Free Survival ◽  
Hazard Ratio ◽  
Stage Iiib ◽  
Cancer Center ◽  
Prior Therapy ◽  
Previously Treated ◽  
Never Smoker

17154 Background: Docetaxel has been standard for second line treatment of NSCLC. In ISEL study, subgroup analyses showed significantly longer survival in the gefitinib group than the placebo group for never-smokers and Asians. It is not clear whether gefitinib has the clinical advantage in these selected patients with NSCLC. We aimed to compare the clinical benefit of gefitinib with that of docetaxel in never smoker previously treated with chemotherapy, retrospectively. Methods: We reviewed patients from August 2002 to September 2005 in Shizuoka Cancer Center. Patients with following conditions were analyzed: NSCLC, received gefitinib or docetaxel, never-smoker, not chemo-naived. We assessed the response rate, progression free survival (PFS) and over all survival for gefitinib and docetaxel respectively. Survival curves were calculated using the Kaplan Meier-method. Prognostic factors were estimated using multivariate analysis. Results: 108 patinets were selected. 69 patients were treated with gefitinib and 39 patients were treated with docetaxel. 28 patients overlapped each other. The patients treated with gefitinib following docetaxel and those with docetaxel following gefitinib were 17 and 13, respectively. 69 patients with gefitinib: the median age, 62 years (31–79); stage IIIB/IV, 14/55; ad/sq/ others, 61/3/5; PS 0/1/2/3, 19/35/13/2; prior therapy containing platinum regimen, 58. The response rate was 36%. 39 patients with docetaxel: the median age, 63 years (31–76); stage IIIB/IV, 8/31; ad/sq/others, 29/7/3; PS 0/1/2/3, 18/19/1/1; prior therapy containing platinum regimen, 34. The response rate was 10%. Gefitinib was superior in longer median PFS (148 days vs 43 days, p = 0.0002). Over all survivals were not significant between two arms. In multivariate analysis for PFS, following factors were significant: gefitinib therapy (hazard ratio 0.375, p = 0.0002); male (hazard ratio 1.854, p = 0.0011); good performance status (hazard ratio 0.450, p = 0.0057). Conclusions: Our results suggested that gefitinib therapy is very attractive for never smoker in the point of PFS. Many patients received cross-over therapies made difficult to analyze over all survival. No significant financial relationships to disclose.

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