The effect of smoking history on survival outcome: An exploratory analysis of a phase III study of gemcitabine and cisplatin in patients with advanced non-small cell lung cancer (NSCLC)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 7141-7141 ◽  
Author(s):  
B. Nguyen ◽  
S. Paul ◽  
K. Posther ◽  
A. Sandler

7141 Background: Exploratory analyses of data from phase II and phase III NSCLC studies of epidermal growth factor receptor (EGFR) inhibitors have shown that smoking history (specifically never smokers) is associated with positive clinical outcomes, indicating increased sensitivity to these agents. A phase III trial in chemonaïve patients (pts) with advanced NSCLC demonstrated that the regimen of gemcitabine-cisplatin is superior to cisplatin alone in terms of response rate, time to disease progression, and overall survival [JCO 2000;18:122–30]. We analyzed data from this trial to examine the effect of smoking history on survival outcome. Methods: All pts entered in the study were combined (524 pts) in a subgroup analysis conducted to evaluate the effect of smoking history (smokers vs non-smokers at baseline; number of never smokers unknown) on survival. In addition, 220 pts with a history of smoking were grouped by the total number of pack-years (pk-yrs) smoked (≤37.5 vs >37.5 pk-yrs), and each group was analyzed with regard to survival relative to the group’s median number of pk-yrs. Results: There was no significant difference in median survival time between smokers (n = 220) and non-smokers (n = 304) (8.5 vs 8.1 months, respectively; hazard ratio [HR]: 0.97 [95% CI: 0.81–1.17]; p-value = 0.739). Although the 112 pts who smoked ≤37.5 pk-yrs had a median of 22.5 pk-yrs and the 108 pts who smoked >37.5 pk-yrs had a median of 55.5 pk-yrs, there was no significant difference in median survival time between the groups (9.2 vs 8.5 months, respectively; HR: 1.00 [95% CI: 0.75–1.34]; p-value = 0.9897). Conclusions: In pts with advanced NSCLC, analyses of survival outcomes for chemotherapy with the combination of gemcitabine-cisplatin or cisplatin indicate that survival is independent of smoking history (smokers vs non-smokers at baseline), unlike targeted therapies, such as EGFR inhibitors for which smoking history (specifically never smokers) is a clinical predictor of the sensitivity of these agents and of survival. [Table: see text]

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 4081-4081
Author(s):  
Brian Warnecke ◽  
Daniel Rosas ◽  
Alexandra Wehbe ◽  
Qianqian Liu ◽  
Joel E Michalek ◽  
...  

Abstract Introduction: Mantle cell lymphoma (MCL) is a rare, aggressive type of B-cell non-Hodgkin lymphoma (NHL) that accounts for approximately 7% of adult NHL's in the United States. (JCO PMID: 9704731)Although recent advancements in treatment have improved survival, prognosis remains poor. (Blood PMID: 30154113) There have been several recent studies demonstrating ethnic disparities in MCL, however, there is a paucity of survival outcome data in Hispanic (H) patients with MCL. (CLMLPMID: 31029647) The purpose of this study was to compare the demographics, treatment patterns, and survival outcomes of H and Non-Hispanic (NH) patients diagnosed with MCL, and to contrast Hispanic cohorts between Texas (TX) and Florida (FL). Methods: This is a retrospective cohort study of patients diagnosed with lymphoma (Hodgkin and Non-Hodgkin) from the Texas Cancer Registry (TCR) and the Florida Cancer Data System (FCDS) from 2006-2017. This particular analysis focuses on patients with diagnosis of MCL. Key variables included gender, race, ethnicity, birthplace, dates of diagnosis and death, primary payer at diagnosis, poverty index, stage at diagnosis, and type of treatment. The significance of variation in distribution of categorical outcomes with ethnicity [H, NH] was assessed with Fisher's Exact tests or Pearson's Chi-square as appropriate; age was assessed with T-test or Wilcoxon. Survival time was measured in years from date of primary diagnosis to date of death. Survival distributions were described with Kaplan-Meier curves and significance of variation in median survival with ethnicity was assessed with log rank testing. All statistical testing was two-sided with a significance level of 0.05. Results: We identified a total 4619 (2078 TX, 2541 FL) patients with MCL. 669 (15%) were H and 3950 (85%) were NH. In TX, the median age of diagnosis was 65.6 years (y) in H and 68.3 y in NH (p < 0.001). In FL, the median age of diagnosis was 67.56 in H and 70.06 in NH (p < 0.001). There was a statistically significant difference in poverty index between the cohorts in both TX and FL. The majority of H (50%) in TX were in the 20-100% bracket while the majority of NH (36%) in TX were in the 10-19.9% bracket (p < 0.001). The majority of H (39%) in FL were in the 10-19.9% bracket, and the majority of NH (35%) were also in the 10-19.9% bracket (p < 0.001). Interestingly, there were only 30% of H in FL in the 20-100% bracket. There was a statistically significant difference in insurance status with the most frequent insurance being government-sponsored insurance for H in TX (48%), NH in TX (58%), H in FL (48%), and NH in FL (62%). Patients were without insurance at time of diagnosis in 14% of H in TX and 9% of H in FL, in contrast to 4% of NH in TX and 2% NH in FL. The most common stage at diagnosis in both cohorts in TX and FL was Stage III/IV with 68% H in TX vs 65% NH in TX (p = 0.746) and 69% H in FL vs 67% NH in FL (p = 0.316). The most frequent chemotherapy regimen included multiple agents for all cohorts, 43% H in TX vs 37% NH in TX (p = 0.063), and 48% H in FL vs 42% NH in FL (p = 0.695). Median survival time was 3.4 y H in TX, 3.5 y NH in TX, 4.1 y H in FL, and 4.3 y NH in FL. The survival probability at 2 years was 0.636, 0.640, 0.707, 0.675 for H in TX, NH in TX, H in FL, and NH in FL, respectively. The survival probability at 5 years was 0.371, 0.379, 0.445, 0.459 for H in TX, NH in TX, H in FL, and NH in FL, respectively. The survival probability at 10 years was 0.147, 0.118, 0.276, 0.245 for H in TX, NH in TX, H in FL, and NH in FL, respectively. There was no statistically significant difference in survival probability at 2, 5, or 10 years between H and NH in TX (p = 0.68) and FL (p = 0.72). Conclusions: Our study of patients diagnosed with MCL demonstrated statistically significant differences between H and NH patients in median age of diagnosis, poverty index, and insurance status at diagnosis. These disparities were observed in patients between the cancer registries in both states. Although there were no statistically significant differences in median survival time or survival probability at 2, 5, and 10 years among the H cohorts within each state, we observed intriguing data when the two states were compared. Strikingly, H in TX had much lower survival probability at 2, 5, and 10 years compared to H in FL. In addition, H in TX were noted to have a shorter median survival time compared to H in FL. These disparities may be a direct reflection of the significantly higher rates of poverty and lack of insurance among H in TX compared to H in FL. Figure 1 Figure 1. Disclosures Diaz Duque: ADCT Therapeutics: Research Funding; Astra Zeneca: Research Funding; Hutchinson Pharmaceuticals: Research Funding; Epizyme: Research Funding.


1998 ◽  
Vol 16 (3) ◽  
pp. 1030-1035 ◽  
Author(s):  
M J Edwards ◽  
J W Gamel ◽  
E J Feuer

PURPOSE The prognosis of breast cancer has improved over the past three decades. It is uncertain, however, whether this improvement results from an increase in the cure rate, extension of the life span of uncured patients, or some combination. METHODS From the Connecticut Tumor Registry, we obtained data on 25,091 patients with localized (node-negative) and regionally metastatic (node-positive) breast cancer who were diagnosed over the two decades between 1965 and 1984, with follow-up through 1993. The data for these patients were analyzed using a variety of parametric models to quantitate likelihood of cure and median survival time among uncured patients. These models incorporate the assumption that time to death from breast cancer follows a specific distribution. RESULTS For patients with node-negative disease, parametric analysis revealed no significant difference in cured-fraction or median survival time over the two decades studied. For patients with node-positive disease, however, a significant increase in median survival time (P < .001) was found during the second decade (1970 to 1979). There was also a trend toward a higher cured-fraction over time, but this was not statistically significant. CONCLUSION This study confirms that patients with node-positive disease had an improved prognosis over the two decades studied. Parametric analysis suggests that this improvement reflects primarily an increase in the median survival time for uncured patients, although there is a trend toward an increase in the likelihood of cure.


2020 ◽  
Vol 38 (4) ◽  
pp. 172-175
Author(s):  
Md Harun Or Rashid ◽  
Quadrat E Elahi ◽  
Md Ashraful Alam ◽  
Fatima Sarker

Background: To compare the survival rate of paclitaxel plus cisplatin (PC arm), paclitaxel plus gemcitabine (PG arm) and gemcitabine plus cisplatin (GC arm) in chemotherapy patients with non resectable lung cancer. Methods: This was a retrospective observational study to evaluate chemotherapy response among non resectable lung cancer patients with their survival at cancer center CMH, Dhaka since 01 July 2013 to 31 March 2015. One hundred fifty-four (154) non resectable lung cancer patients were randomly divided into three groups, 50 patients in PC arm, 51 patients in PG arm and 53 patients in GC arm. In PC arm paclitaxel 175 mg/m2 (day 1) with cisplatin 75mg/m2 (day 1), in PG arm Paclitaxel 175 mg/m2 (day 1) with gemcitabine 1000 mg/m2 (days 1 and 8) and in GC arm gemcitabine 1000 mg/m2 (days 1 and 8) with cisplatin 100mg/m2 (day 1). Results: Patients characteristics were similar between the three groups. The overall response rate was 40% in the PC arm,43.1% in the PG arm, 43.4% in the GC arm. The median survival time in PC arm was 8.5 months, in PG arm was 8.8 months, in GC arm was 9.2 months. The major side effect was myelosuppression which accounts 71% patients. The average treatment costs were 57% and 30% lower in PC arm as compared with GC and PG arm respectively. Conclusion: The median survival time, disease free survival time and 1-year survival rate in PC, PG, GC arms without significant difference. Treatment were well tolerable; quality of life parameter was mostly similar but paclitaxel with cisplatin was most cost effective than others chemotherapy regimen. J Bangladesh Coll Phys Surg 2020; 38(4): 172-175


Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 4482-4482
Author(s):  
Wei Wu ◽  
Yong-quan Xue ◽  
Ya-fang Wu ◽  
Jin-lan Pan ◽  
Juan Shen

Abstract Objective: To determine the frequency of the deletion of derivative 9 [der(9)] among chronic myeloid leukemia (CML) patients with classic Ph translocation and variant Ph translocation, and to assess the association between this deletion and clinical prognosis. Methods: Cytogenetical analysis of bone marrow cells was performed by direct method and /or 24h culture method. RHG banding was used for karyotype analysis. Dual-color and dual-fusion DNA probe was used to perform interphase-FISH to investigate the deletion of der(9) in Ph+ CML patients and all patients were followed up. Result: Cytogenetical studies showed typical Ph translocation in 76/105 and variant Ph translocation in 29/105. Interphase-FISH studies showed deletion of der(9) in 12 cases(15.8%) of 76 patients with classic Ph translocation and in 4 cases (13.7%) of 29 patients with variant translocation. The frequency of deletion was similar in classic and variant translocations (P>0.9). This result is contrary to previous reports which suggested that deletions are much more common in variant Ph translocation than in classic Ph translocation. When the deletion was seen in a patient, it was present in all the Ph+ metaphases and nuclei. Three patients with heterogeneous cell populations mixed with cells with single 5′-ABL or 3′-BCR deletion and with both 5′-ABL and 3′-BCR deletion. It may suggest clone evolution in the progression of deletion. Complete clinical information was available in 54 patients. There were no significant difference in peripheral leukocyte count, platelet count, hemoglobin and percentage of peripheral blood blast cells between patients with and without der(9)deletion. However, the results of following up showed that the median survival time of patients with der(9) deletion was significantly shorter than those without der(9) deletion (34 months vs 76 months; P<0.05, log-rank Test). Conclusion: A deletion of der(9) is seen in about 1/6 Ph+ CML patients in china, with which Ph+ CML patients have shorter median survival time than those without it, indicating that it is a poor prognostic index. For evolution the prognosis of CML patients more precisely, it is best to perform cytogenetical analysis and FISH analysis for der(9) deletion simultaneously at diagnosis.


2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 7109-7109 ◽  
Author(s):  
J. Von Pawel ◽  
K. Park ◽  
J. R. Pereira ◽  
A. Szczesna ◽  
C. Yu ◽  
...  

7109 Background: Cisplatin plus vinorelbine is a commonly used regimen for first-line therapy of advanced NSCLC, achieving response rates of 20–30% and median survival times of 6 to 11 months (mths). An earlier phase II trial investigated cetuximab in combination with cisplatin and vinorelbine in this setting and found improved response rates in the cetuximab arm, warranting this larger phase III trial. Methods: Patients (pts) with EGFR-expressing advanced NSCLC (stage IIIB with documented malignant pleural effusion and stage IV) were randomized 1:1 either to Group A (cetuximab 400 mg/m2 initial dose then 250 mg/m2 weekly, cisplatin 80 mg/m2 on day 1, vinorelbine 30 mg/m2 on day 1 and 8) or to Group B (cisplatin and vinorelbine as before) for a maximum of 6 three-weekly cycles. Cetuximab was administered until progression or unacceptable toxicity. Primary endpoint is overall survival time; secondary endpoints are progression-free-survival, tumor response, disease control, safety, and quality of life. Enrollment of 1,100 pts was planned to show an increase of median survival time of 25% with 90% power. The Data Safety Monitoring Board (DSMB) performed an independent preplanned safety analysis from the first 370 pts. Patients were followed for a minimum of 6 weeks (2 cycles). Results: Since November 2004, 1,037 pts have been randomized, 689 are under treatment, and 348 pts have discontinued the study. Demographics of the first 370 pts reflected known advanced NSCLC characteristics: 91% stage IV, median age 60 yrs (31–79), 38% female, 80% ECOG PS 0/1, 52% adenocarcinoma, 30% squamous cell carcinoma; 29% never-smokers, 17% Asian. The ten most frequent adverse events were: nausea, neutropenia, vomiting, anorexia, fatigue, constipation, anemia, febrile neutropenia, rash, and diarrhoea. Conclusions: The trial continued after review of all relevant baseline and safety information from the first 370 pts. Recruitment is ongoing. [Table: see text]


Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 2687-2687
Author(s):  
Kathrin Nachtkamp ◽  
Corinna Strupp ◽  
Andrea Kuendgen ◽  
Norbert Gattermann ◽  
Rainer Haas ◽  
...  

Abstract Introduction: Patients with higher-risk MDS, especially those with an IPSS score of intermediate-2 or high, face a very poor prognosis with a median survival of 12 to 18 months. Allogeneic transplantation as a curative approach is an option for only a small percentage of patients. In phase-III-trials, hypomethylating agents demonstrated a survival benefit for this patient group. In order to validate the use of these compounds in clinical day-to-day practice, we analyzed 40 patients who underwent hypomethylating treatment with either decitabine or 5-azacytidine. Methods: We performed matched-pairs analyses using the Düsseldorf MDS registry (n=3288). Patients with higher-risk MDS (INT-1, INT-2, or high-risk IPSS scores) at the time of treatment with hypomethylating agents (n=40) were compared with higher-risk MDS patients who received best supportive care (BSC) only (n=120) and with higher-risk MDS patients who underwent treatment with low-dose Ara-C (n=35). Patients were matched according to age, gender, WHO type, IPSS score and date of diagnosis. Each patient in the hypomethylating cohort was matched with three patients of the BSC cohort and one patient of the low-dose ara-C cohort. For 5 patients, no adequate match partner of the low-dose ara-C cohort could be assigned. Follow-up for survival was assured by contacting our outpatient department or primary care physician. Results: The distribution of WHO types at time of diagnosis within the decitabine/5-azacytidine cohort was 10 RA/RCMD patients, 9 RAEB I, 16 RAEB II, 2 CMML I and 3 CMML II. Median age was 70 years. 10 patients belonged to the intermediate-1, 11 to the intermediate-2 and 18 patients to the high-risk group according to the IPSS score. In one patient, the IPSS score could not be assessed. All patients had progressed to at least RAEB II when treatment was initiated. 19 patients received decitabine and 21 patients were given 5-azacytidine. Median survival time in the hypomethylating cohort was 28 months, regardless of the type of hypomethylating treatment, compared with 10 months in the BSC cohort. Figure 1 shows the Kaplan Meier curve comparing 40 patients treated with hypomethylating agents with 120 patients who received BSC only (p=0.0026). Median survival time of the low-dose ara-C cohort was 20 months; although 5 patients of the hypomethylating cohort could not be assigned a match partner and therefore had to be withdrawn from the comparison with low-dose ara-C, median survival in the remaining 35 patients of the hypomethylating cohort was still 28 months. Figure 2 shows the Kaplan Meier curve comparing the hypomethylating cohort with the low-dose ara-C cohort (p=0.027). Conclusions: Our data show that higher-risk MDS patients have a substantial survival benefit from treatment with hypomethylating agents as compared to both low-dose ara-C and BSC patients. Hypomethylating agents should be considered to be the treatment of choice in higher-risk MDS patients who are not candidates for allografting. Figure Figure


2003 ◽  
Vol 21 (14) ◽  
pp. 2636-2644 ◽  
Author(s):  
Nicholas J. Vogelzang ◽  
James J. Rusthoven ◽  
James Symanowski ◽  
Claude Denham ◽  
E. Kaukel ◽  
...  

Purpose: Patients with malignant pleural mesothelioma, a rapidly progressing malignancy with a median survival time of 6 to 9 months, have previously responded poorly to chemotherapy. We conducted a phase III trial to determine whether treatment with pemetrexed and cisplatin results in survival time superior to that achieved with cisplatin alone. Patients and Methods: Chemotherapy-naive patients who were not eligible for curative surgery were randomly assigned to receive pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 on day 1, or cisplatin 75 mg/m2 on day 1. Both regimens were given intravenously every 21 days. Results: A total of 456 patients were assigned: 226 received pemetrexed and cisplatin, 222 received cisplatin alone, and eight never received therapy. Median survival time in the pemetrexed/cisplatin arm was 12.1 months versus 9.3 months in the control arm (P = .020, two-sided log-rank test). The hazard ratio for death of patients in the pemetrexed/cisplatin arm versus those in the control arm was 0.77. Median time to progression was significantly longer in the pemetrexed/cisplatin arm: 5.7 months versus 3.9 months (P = .001). Response rates were 41.3% in the pemetrexed/cisplatin arm versus 16.7% in the control arm (P < .0001). After 117 patients had enrolled, folic acid and vitamin B12 were added to reduce toxicity, resulting in a significant reduction in toxicities in the pemetrexed/cisplatin arm. Conclusion: Treatment with pemetrexed plus cisplatin and vitamin supplementation resulted in superior survival time, time to progression, and response rates compared with treatment with cisplatin alone in patients with malignant pleural mesothelioma. Addition of folic acid and vitamin B12 significantly reduced toxicity without adversely affecting survival time.


Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 17-20
Author(s):  
Michael E Auster ◽  
Snegha Ananth ◽  
Lakene Raissa Djoufack Djoumessi ◽  
Qianqian Liu ◽  
Joel E Michalek ◽  
...  

BACKGROUND: Social determinants and demographics exert an overwhelming influence on the health of the individual and overall population health (J Am Geriatr Soc. PMID: 28369694).The Hispanic paradox has been well characterized, demonstrating that although Hispanic patients (HisP) have higher disability, depressive, metabolic, and inflammatory risk when compared to non-Hispanic (nHisP), they continue to live long lives (J Health Soc Behav. PMID: 31771347). The characterization of these differences in hematology has not been well documented. This study seeks to characterize Lymphoplasmacytic lymphoma (LPL). LPL is a rare lymphoma of B-cell origin demonstrating an incidence of 1000 to 1500 new cases per year in the United States (Hematol Oncol Clin North Am, PMID: 31229160). Epidemiological research is not well documented in this lymphoma subtype, especially regarding the HisP. Given that Texas has the second highest state with HisP in the country (US Census Bureau), we studied the demographics of this disease and specifically researched the demographics, treatment patterns and survival between HisP and nHisP in Texas. METHODS: This is a retrospective study of a cohort of patients diagnosed with lymphoma (Hodgkin and Non-Hodgkin) from the Texas Cancer Registry (TCR) database. Patient's included were those &gt;18 years of age during 2006-2016 and this study focused on the LPL subset. Standard demographic variables collected include gender, race, ethnicity, birthplace, occupation, dates at diagnosis and death, primary payer at diagnosis, subtype of lymphoma, stage, type of treatment, poverty index, and vitality status among others. The significance of variation in the distribution of categorical outcomes with ethnicity (HisP, nHisP) was assessed with Fisher's Exact tests or Pearson's Chi-square tests as appropriate; age was assessed with T-tests or Wilcoxon tests as appropriate. Survival time was measured in years from date of primary diagnosis to date of death. Survival distributions were described with Kaplan-Meier curves and significance of variation in median survival with ethnicity was assessed with log rank testing. All statistical testing was two-sided with a significance level of 5%. RESULTS AND DISCUSSION: Out of 490 patients diagnosed with LPL, 64 were HisP and 426 nHisP. Of this population, the HisP had a higher percentage of patients at the higher end of the poverty index (42.4% to 20% with p value &lt;0.001) and higher rates of being uninsured or on Medicare (51.6 to 43.4% with p value &lt;0.001). There were no statistically significant differences in the staging at the time of diagnosis between the two groups, mostly III/IV (HisP 65.6% to nHisP 62% P value 0.387). Treatment modalities differed slightly in that the nHisP populations were more likely to receive beam radiation than the HisP (3.4% to 0, P value 0.005) but overall chemotherapy differences were not statistically significant. The median survival time in years for HisP and nHisP was 6.8 and 7.6 respectively, and the overall survival probability was not significantly different with a P value of 0.59. The survival probabilities at 2, 5 and 10 years between HisP and nHisP were respectively, 0.657 with Confidence interval (CI)[0.545,0.792], 0.573 CI [0.455,0.722], 0.448 CI [0.32,0.627], compared to 0.766 CI [0.723,0.811], 0.620 CI [0.566,0.68], 0.129 CI [0.042,0.389]. CONCLUSION: In this study we show that in Texas, for those diagnosed with LPL, there is a statistically significant difference in the rates of poverty and insurance when comparing Hisp to nHisP. While this is true, there is no clear statistically significant difference in overall treatment or survival probability, which is consistent with the Hispanic paradox. Due to the rarity of this disease, the population size is limited which may skew the data. More research is needed in order to further characterize the differences between these two populations and determine what can be done to narrow these differences. Disclosures Diaz Duque: ADCT Therapeutics: Research Funding; Molecular Templates: Research Funding; AstraZeneca: Research Funding; Hutchinson Pharmaceuticals: Research Funding; Seattle Genetics: Speakers Bureau; Verastem: Speakers Bureau; AbbVie: Speakers Bureau.


2008 ◽  
Vol 26 (15) ◽  
pp. 2450-2456 ◽  
Author(s):  
Karen Kelly ◽  
Kari Chansky ◽  
Laurie E. Gaspar ◽  
Kathy S. Albain ◽  
James Jett ◽  
...  

PurposeEarly clinical studies with gefitinib showed promising efficacy and mild toxicity in patients with advanced non–small-cell lung cancer (NSCLC). Thus, gefitinib was an ideal agent to evaluate in a maintenance setting in stage III disease.Patients and MethodsUntreated patients with stage III NSCLC, a performance score of 0 to 1, and adequate organ function were eligible. All patients received cisplatin 50 mg/m2on days 1 and 8 plus etoposide 50 mg/m2on days 1 to 5, every 28 days for two cycles with concurrent thoracic radiation (1.8- to 2-Gy fractions per day; total dose, 61 Gy) followed by three cycles of docetaxel 75 mg/m2. Patients whose disease did not progress were randomly assigned to gefitinib 250 mg/d or placebo until disease progression, intolerable toxicity, or the end of 5 years. The planned sample size was 672 patients to confer power of 0.89 to detect a 33% increase over the expected median survival time of 21 months (one-sided P = .025, log-rank test). Random assignment was stratified by stage, histology, and measurable versus nonmeasurable disease.ResultsEnrollment began in July 2001. An unplanned interim analysis conducted in April 2005 rejected the alternative hypothesis of improved survival at the P = .0015 level for 243 randomly assigned patients. The study closed, and preliminary results were reported. Now, with a median follow-up time of 27 months, median survival time was 23 months for gefitinib (n = 118) and 35 months for placebo (n = 125; two-sided P = .013). The toxic death rate was 2% with gefitinib compared with 0% for placebo.ConclusionIn this unselected population, gefitinib did not improve survival. Decreased survival was a result of tumor progression and not gefitinib toxicity.


2016 ◽  
Vol 2016 ◽  
pp. 1-6 ◽  
Author(s):  
Yang Chen ◽  
Hong Zhu ◽  
Feng Xu ◽  
Yidan Cao ◽  
Xingting Gu ◽  
...  

We performed a retrospective analysis of 21 patients with primary gastric squamous cell carcinoma (PGSCC) who were admitted to our hospital from October 2008 to October 2014. The median age was 67 years and male predominance was observed, the most common tumor locations were the upper third of the stomach, most of the clinical manifestations were identical to those of other types of gastric tumors, and the tumor cells had positive immunoreactivity for p63 and CK5/6. In terms of treatments, surgery (R0 resection) is the main treatment; the effect of other treatments is unclear. The median survival time for the surgery group and nonsurgery group was 46 and 4.5 months, respectively. Probably due to limited number of cases, no significant difference in median survival time was observed between the surgery alone group and the surgery plus adjuvant therapy group (46 versus 51 months,P=0.310). A standard chemotherapy regimen for this disease has not yet been established; the choice of its chemotherapy regimens tends to follow the principle of the treatment of gastric adenocarcinoma or esophageal cancer. PGSCC generally had a poor prognosis, and early detection, early diagnosis, and early surgical treatment are beneficial to patients.


Sign in / Sign up

Export Citation Format

Share Document