The Surgical Treatment and Outcome for Primary Duodenal Adenocarcinoma

Background

The purpose of this study was to investigate the early diagnosis and outcomes of surgical treatment of primary duodenal adenocarcinoma (PDAC) for curative purpose.

Method

Thirty-two PDAC patients treated surgically between February 1990 and September 2006 were analyzed retrospectively.

Results

All 32 patients underwent laparotomy, including 18 patients (56.3%) pancreaticoduodenectomy (PD), six patients (18.7%) segmental resection (SR), and eight patients bypass procedures. R0 resections were obtained in 22 patients; the other 10 procedures were palliative. The total 1-, 3-, and 5-year survival rates in this study were 86.2% (25/29), 48.3% (14/29), and 20.7% (6/29), respectively, moreover, the 1-, 3-, and 5-year survival rates in patients with R0 resection were 100.0% (19/19), 73.7% (14/19), and 31.6%(6/19), which were significantly higher than those (50.0%?=?5/10, 0%, and 0%) in patients with palliative operation (P?>?0.05), respectively. Furthermore, the 5-year survival rate was 27.8% (5/18) in pancreaticoduodenectomy patients and 16.7% (1/6) in segmental resection patients, and there was no significant difference between the above two procedures (P?>?0.05).

Conclusion

PD is suggested for tumor located at the first and second portion of the duodenum, and SR may be appropriate for the selected patients, especially for tumors of the distal duodenum.     

The Surgical Treatment and Outcome for Primary Duodenal Adenocarcinoma

Background

Primary duodenal adenocarcinomas (PDAC) are uncommon tumors characterized by non-specific symptoms and late diagnosis, and treatments of PDAC have some controversies.

Method

To investigate the early diagnosis and outcomes of surgical treatment of PDAC, 32 patients who were treated surgically between February 1990 and September 2006 were analyzed retrospectively.

Results

All 32 patients underwent laparotomy, including 18 patients (56.3%) with pancreaticoduodenectomy (PD), six patients (18.7%) with segmental resection (SR), and eight patients with bypass procedures. And, R0 resections were obtained in 22 patients; the other ten procedures were palliative. The total 1-, 3-, and 5-year survival rates in this study were 86.2% (25 of 29), 48.3% (14 of 29), and 20.7% (six of 29), respectively. Moreover, the 1-, 3-, and 5-year survival rates in patients with R0 resection were 100.0% (19 of 19), 73.7% (14 of 19), and 31.6% (six of 19), which were significantly higher than those (50.0%?=?5/10, 0% and 0%) in patients with palliative operation (P?<?0.05), respectively. Furthermore, the 5-year survival rate was 27.8% (five of 18) in pancreaticoduodenectomy patients and 16.7% (one of six) in segmental resection patients, and there was no significant difference between the above two procedures (P?>?0.05).

Conclusion

PD is suggested for the tumor located at the first and second portion of the duodenum, and SR may be appropriate for the selected patients, especially for tumors of the distal duodenum.     

Utility of Serum CA19-9 Levels in the Diagnosis of Pancreatic Ductal Adenocarcinoma in an Endoscopic Ultrasound Referral Population

Purpose

Recent data suggest the use of carbohydrate antigen (CA) 19-9 as a potential marker in the early detection of pancreatic ductal adenocarcinoma (PDAC) when used in the appropriate clinical setting. Here, we assess the utility of CA19-9 in PDAC detection in a select population of pancreatic endoscopic ultrasound (EUS) referrals.

Methods

Retrospective review of an institutional EUS Pancreas Registry containing cases referred from November 2002 to November 2011 was completed for categorical analyses with CA19-9 level. A separate case–control study for the subset of non-elevated CA19-9 PDAC population was also performed to characterize the clinical features in this unique group of patients.

Results

Two hundred eighty-three patients had available CA19-9 data in the registry and were included in the study. Compared to the typical PDAC distribution, the proportion of patients with stage I disease was significantly higher in our registry population (P?<?0.0001). Elevated CA19-9 levels most often reflected a diagnosis of PDAC relative to other pancreaticobiliary diagnoses. However, we observed that 15 % of patients with PDAC had normal CA19-9 levels. Clinical characteristics for this false-negative PDAC group compared to the true-positive group demonstrated a predilection for detection of cancer in the body/tail of the pancreas (P?=?0.03), increased likelihood of lymph node metastases (P?=?0.03), and initial presentation with vague abdominal pain or pancreatic mass as an incidental finding on imaging studies (P?=?0.01).

Conclusions

Elevated CA19-9 demonstrated a greater likelihood of PDAC diagnosis relative to benign pancreatic pathology, and higher levels of CA19-9 were in line with worse PDAC stage. Patients with normal CA19-9 PDAC may represent a unique subclass of patients, presenting with atypical clinical features, and possibly more advanced stage disease at the time of diagnosis. These patients may benefit from more diligent EUS examination or perhaps closer follow-up management.     

Multivariate analysis of immunohistochemical evaluation of protein expression in pancreatic ductal adenocarcinoma reveals prognostic significance for persistent Smad4 expression only

Background

Pancreatic ductal adenocarcinoma (PDAC) has a dismal prognosis with a 5-year survival rate of <5% and an average survival of only 6?months. Although advances have been made in understanding the pathogenesis of PDAC in the last decades, overall survival has not changed. Various clinicopathological and immunohistological variables have been associated with survival time but the exact role that these variables play in relation to survival is not clear.

Methods and results

To examine how the variables affected survival independently, multivariate analysis was conducted in a study group of 78 pancreatic ductal adenocarcinomas. The analysis included clinicopathological parameters and protein expression examined by immunohistochemistry of p53, Smad4, Axl, ALDH, MSH2, MSH6, MLH1 and PMS2. Lymph node ratio <0.2 (p?=?0.004), tumor free resection margins (p?=?0.044) and Smad4 expression (p?=?0.004) were the only independent prognostic variables in the multivariate analysis. Expression of the other proteins examined was not significantly related to survival.

Conclusions

Discrepancies with other studies in this regard are likely due to differences in quantification of immunohistochemical staining and the lack of multivariate analysis. It underscores the importance to standardize the methods used for the application of immunohistochemistry in prognostic studies.     

Radical surgery of oligometastatic pancreatic cancer

Background

In metastatic disease (M1), chemotherapy (expected survival: 6–10 months) is considered the only treatment option. The aim of this study was to evaluate the outcome of curative M1 PDAC resections.

Long-Term Results and Prognostic Factors in Resected Pancreatic Body and Tail Adenocarcinomas

Background

Adenocarcinoma of the body and tail of the pancreas are more often than not inoperable to begin with. Factors predicting the prognosis in the resected tumors of pancreatic body and tail were analyzed.

Methods

Between 1989 and 2006, 43 patients with adenocarcinoma of the body and tail of the pancreas underwent resection at Chang Gung Memorial Hospital, Taoyuan, Taiwan. Univariate and multivariate analysis of clinicopathological factors affecting the prognosis were analyzed.

Results

Totally, 32 patients were available for the analysis. The median follow-up was 13.6 months (1.5–87.5 months). The median survival time was 14.2 months and the 1-, 3-, and 5-year survival rates were 58.1, 25.8, and 6.5 %, respectively. On univariate analysis, the factors which influenced the survival were tumor size >4 cm (p?=?0.004), lymphatic invasion (p?=?0.001), and positive resection margin (p?=?0.030). On multivariate analysis, only the tumor size and the lymphatic invasion were independent prognostic factors.

Conclusion

Even after macroscopic curative resection, the prognosis remains poor for pancreatic body and tail adenocarcinoma. Early diagnosis is the key to achieving long-term survival. Newer effective adjuvant treatment after curative resection is needed to improve the survival     

The surgical prognosis of pIIIA/N2 non-small-cell lung cancers

Objective

The aim of the study was to identify prognostic factors in non-small-cell lung cancer (NSCLC) with N2 nodal involvement.

Methods

A retrospective analysis of disease free survival and 5-year survival for NSCLC patients who underwent primary surgical resection without neoadjuvant chemotherapy were performed. Between January 1998 and May 2004, 133 patients were enrolled. Several factors such as age, sex, skip metastasis, number of N2 lymph node stations, type of resection, histology, adjuvant therapy etc., were recorded and analyzed. SPSS 16.0 software was used.

Results

Overall 5-year survival for 133 patients was 32.33%, 5-year survival for single N2 station and multiple N2 stations sub-groups were 39.62% and 27.50% respectively, and 5-year survival for cN0?C1 and cN2 sub-groups were 37.78% and 20.93% respectively. COX regression analysis revealed that number of N2 station (P = 0.013, OR: 0.490, 95% CI: 0.427?C0.781) and cN status (P = 0.009, OR: 0.607, 95% CI: 0.372?C0.992) were two favorable prognostic factors of survival.

Conclusion

Number of N2 station and cN status were two favorable prognostic factors of survival. In restrict enrolled circumstances, after combined therapy made up of surgery and postoperative adjuvant therapy have been performed, satisfied survival could be achieved.     

Docetaxel-Based Preoperative Chemoradiation in Localized Gastric Cancer: Impact of Pathological Complete Response on Patient Outcome

Purpose

This study was conducted to evaluate the feasibility, efficacy, and toxicities of docetaxel-based induction chemotherapy and chemoradiotherapy in patients with localized gastric or gastroesophageal adenocarcinoma.

Methods

Patients with localized, operable gastric or gastroesophageal adenocarcinoma received two cycles of induction chemotherapy of fluorouracil, docetaxel, and cisplatin (TPF) followed by 45 Gy of radiation and concurrent fluorouracil plus docetaxel then surgery for nonmetastatic patients.

Results

Forty-one patients were included. Pretreatment T3 was encountered in 56 % of patients while 61 % had N1 disease. A pathologic complete response (CR) was noted in 24 % of patients. Pathologic response was significantly associated with baseline T stage (P?<?0.001) and N stage (P?=?0.002). The 3-year overall survival (OS) and disease-free survival were 47.3 and 42.1 %, respectively. OS was significantly correlated with R0 resection (P?=?0.027), pathological response (P?=?0.01), dissected pathologically positive lymph node (P?=?0.037), and postsurgery (T) stage (P?=?0.02). Toxicities were manageable and there were no treatment-related deaths.

Conclusion

Docetaxel-based chemoradiotherapy in localized gastric adenocarcinoma patients resulted in 24 % path CR and was not associated with a higher percentage of postoperative complications. A well-designed randomized controlled trial is mandatory to further endorse this evolving approach.     

Early initiation of adjuvant chemotherapy improves survival of patients with pancreatic carcinoma after surgical resection

Purpose

Adjuvant chemotherapy is accepted as a standard treatment after surgical resection of pancreatic carcinoma; however, the optimal timing between surgery and initiation of adjuvant chemotherapy has not been reported. The aim of this study was to determine the optimal timing of adjuvant chemotherapy after surgical resection of pancreatic carcinoma.

Methods

Records of 104 patients who received adjuvant chemotherapy after curative surgical resection of pancreatic carcinoma were reviewed retrospectively. Patients were grouped according to whether they received initial adjuvant chemotherapy within 20 days after surgery (≦20 days, n = 57) or more than 20 days after surgery (>20 days, n = 47). Relationships between time to initiation of adjuvant chemotherapy, other clinicopathological factors, and survival were analyzed.

Results

The rate of postoperative complication was significantly lower than in the ≦20 days group compared with the >20 days group (P = 0.003); no significant difference in other clinicopathological factors was found. Multivariate analysis revealed that time to initiation of adjuvant chemotherapy was an independent prognostic factor of disease-free survival (P = 0.009) and overall survival (P = 0.037). The ≦20 days group had longer 5-year overall survival rates than did the >20 days group (52 vs. 26 %, P = 0.013) as well as longer 5-year disease-free survival rates (53 vs. 22 %, P = 0.007).

Conclusions

Adjuvant chemotherapy for patients with resected pancreatic carcinoma should be initiated as soon as possible after surgical resection. Prevention of postoperative complication is needed to enable early initiation.     

Development of treatment and clinical results in childhood acute myeloid leukemia in Slovenia in the period from 1991 to 2010

Background

A review of treatment and survival of children with acute myeloid leukemia (AML) in Slovenia from 1991 to 2010.

Methods

We collected demographic data, information on the time, and course of treatment of patients with AML, which were classified in three risk groups and treated according to standard arm of BFM AML protocols 83, 93, 98, and 04. We assessed the rate of remission, event-free survival and overall survival, the incidence of relapse, the secondary neoplasms, secondary AML, the proportion of patients treated with hematopoietic stem cell transplantation (HSCT) and causes of death. The 2- and 5-year overall survival (5yOS) was estimated according to age group, risk group, the presence of remission, and the time of the treatment.

Results

There were 50 patients, 18 males (36?%) and 32 females (64?%) included in this study. Secondary AML was presented in four patients. Patients treated with HSCT were 18 (36?%), 9 of them in first remission. The 2-year overall survival (2yOS) was 63.7?±?6.8?% and 5-year survival was 55.0?±?7.2?%. Differences in survival between age groups (0–5 years, 6–10 years and more than 10 years) was not significant. All patients in standard risk group lived for more than 2 years, in high-risk group 2yOS was 56.7?±?7.7?% (p?=?0.05). Patients who were in remission before second treatment block had 2yOS 77.8?±?7.4?% and 5yOS 63.8?±?8.8?%, compared to the patients who were not in remission (2yOSand 5yOS 37.5?±?12.1?%, p?=?0.001). The 2yOS in patients treated with HSCT in first remission was 62?%. There were 17 patients (34?%) who had relapse of the disease, 23 (64?%) patients died, 14 (61?%) due to progression of the disease.

Conclusions

The results of treatment of AML in our center are comparable with other European centers. Survival was better in the standard risk group and in patients who were in remission before second treatment block. We observed a trend of improvement in survival in the time observed.     

Impact of Preoperative and Postoperative FOLFOX Chemotherapies in Patients with Resectable Colorectal Liver Metastasis

Purpose

Whether the survival benefit of perioperative FOLFOX in patients with liver metastases of colorectal cancer (LMCRC) is provided by preoperative chemotherapy (CT), postoperative CT, or both remains unclear. This study aimed to evaluate, in patients with resectable LMCRC, the survival impact of preoperative and postoperative separately.

Methods

Between 2000 and 2010, the 179 patients (126 men, age 61?±?11 years) with initially resectable LMCRC, who underwent liver resection (LR) and were offered pre- and/or postoperative FOLFOX were included. Twenty-four (13 %) patients did not receive CT, 27(15 %) patients received only preoperative CT, 71 (40 %) patients received only postoperative CT, and 57 (32 %) patients received both pre- and postoperative CT.

Results

Operative morbidity and mortality rates were 19 and 0.6 %, respectively. At 1, 3, and 5 years, OS and DFS rates were 97, 66, 46 and 60, 32, and 24 %, respectively. Postoperative FOLFOX was an independent predictor of increased OS (HR?=?0.55 [95 % CI, 0.35–0.87] p?=?0.01) and DFS (HR?=?0.54 [0.36–0.82] p?=?0.0017), whereas the synchronous onset of the metastasis and the presence of radiographically occult liver metastases were independent predictors of poorer OS. Alternatively, preoperative FOLFOX had no significant influence on OS (HR?=?0.96 [0.57–1.60] p?=?0.83) or DFS (HR?=?1.05 [0.66–1.66] p?=?0.87).

Conclusions

The survival benefit of FOLFOX in patients with resectable LMCRC may be provided by postoperative rather than preoperative administration.     

Analysis of Super-low Anterior Resection for Rectal Cancer from a Single Center

Purpose

The purpose of this study was to evaluate the outcome and genitourinary complications of super-low anterior resection (SLAR) followed by adjuvant radiochemotherapy in the management of patients with low rectal cancer.

Method

One hundred and six low rectal cancer patients managed with SLAR were analyzed retrospectively.

Results

There were seven patients who failed to follow up, and the 5-year survival rate was 65.7% (65/99). There were 35 patients (35.4%) who developed distant metastases, and 12 (12.1%) had local recurrence. The local recurrence rates were 21.1% (4/19), 7.1% (2/28), 5.9% (1/17), and 0% (0/2) in the patients with tumor distance of less than or equal to 2 cm, ranging from 2.1 to 3.0, from 3.1 to 4.0, from 4.1 to 5.0, and more than 5 cm, respectively. This implied local recurrence rate increased against the distance between the lower margin of tumor and resection line. Ninety-eight of 106 rectal patients had complete data of questionnaire: 58 scored 1, 32 scored 2, 7 scored 3, and 1 score 4. This revealed that the fecal function of most patients (91.8%, 90/98) was normal or nearly normal. Twenty-four of 37 males suffered from sexual dysfunction, and among them, eight were impotent (all older than 70 years), and 29 had retrograde ejaculation. Meanwhile, seven of 35 females suffered from sexual problem, 1 had dyspareunia, seven had decreased lubrication, and one had inability to achieve orgasm.

Conclusions

SLAR followed by adjuvant radiochemotherapy can effectively control local–regional disease and can be one choice of avoiding the functional morbidity of abdominoperineal resection.     

Long-term results with oral fluoropyrimidines and oxaliplatin-based preoperative chemoradiotherapy in patients with resectable rectal cancer. A single-institution experience

Introduction

Neoadjuvant 5-FU-based chemoradiotherapy in resectable rectal cancer (RC) is a standard of treatment. The use of oral fluoropyrimidines and new agents such as oxaliplatin may improve efficacy and tolerance.

Material and methods

Between 1999 and 2009, 126 RC patients with T3?CT4 and/or N+ disease were given three successive protocols: UFT (32), UFT-oxaliplatin (75) and capecitabine-oxaliplatin (19), alongside 45 Gy of radiotherapy; with surgery 4?C6 weeks after. Adjuvant treatment was given in all patients. The primary objective was pathologic complete response (pCR).

Results

Preoperative therapy was well tolerated, with no toxic deaths and a 15% grade 3?C4 toxicity rate. Eighty-five percent of patients received the full chemotherapy dose, 56% had an abdominoperineal resection, 6% reinterventions and 57% received the full adjuvant chemotherapy planned. The pCR rate was 13%. The downstaging rate was 80%; 8% had progression of disease. The relapse rate was 20%, with local relapse in 6%. By 5 years of followup, 92% of relapses had occurred. Median follow-up was 73 months, 5- and 10-year disease-free survival rates were 75% and 50%, and 5- and 10-year overall survival rates were 79% and 66% respectively. There was no benefit from the use of oxaliplatin regarding survival or pCR rates. Older patients had worse long-term outcomes.

Conclusions

Neoadjuvant chemoradiotherapy with oral fluoropyrimidines and oxaliplatin is feasible and well tolerated. The risk of early progression is low. However, there was no added benefit with the use of oxaliplatin. There were no relapses in patients with pCR. The role of adjuvant chemotherapy is unclear.     

Characteristics of Colorectal Cancer Survival in an Urban County Hospital

Purpose

Disparities in colorectal cancer (CRC) survival have been associated with race/ethnicity, screening, and insurance status, but less is known about how geographic and socioeconomic heterogeneity may modulate these factors. We examined CRC outcomes in an urban underserved population with sociodemographic factors distinctly different than those previously studied.

Methods

In this 11-year retrospective study, the demographics and clinical features of 331 CRC patients from a Northern California urban county hospital were reviewed. Cox proportional hazards modeling was used to evaluate differences in 5-year mortality.

Results

The study cohort consisted of 38 % Whites, 37 % Asians, 22 % Hispanics, and 4 % Blacks. Most of the patients either had government-sponsored insurance (62.5 %) or were uninsured (21.8 %). Compared to national SEER data, stage IV disease was more prevalent in our study cohort (37 vs 20 %) and the overall 5-year survival rate was worse (52.9 vs 64.3 %). CRC screening was associated with improved survival (hazard ratio (HR) 0.24, P?=?0.002), while insurance status was not. In the multivariate analysis, advanced age (HR 2.48, confidence interval (CI) 1.39–4.42, P?=?0.002) and late stage (stage IV: HR 32.46, CI 9.92–106.25, P?<?0.001) predicted worse outcomes. Contrary to some population-based studies, Hispanics in our cohort had significantly better overall mortality compared to Whites (HR 0.46, CI 0.29–0.74, P?=?0.001).

Conclusions

Disparities in CRC outcomes for urban underserved populations persist. However, there is geographic and socioeconomic heterogeneity in factors that have been previously shown to contribute to mortality. Screening and therapeutic strategies formulated from larger population-based studies may not be generalizable to these unique subpopulations.     

Successful treatment of infants with localized neuroblastoma based on their MYCN status

Background

The aim of this study was to evaluate the effectiveness of post-surgical chemotherapy for infants with localized neuroblastoma without MYCN amplification (MNA), and determine whether risk classification using MNA is reasonable.

Methods

Four hundred and fourteen eligible patients were registered between 1998 and 2004. Resectable patients in stage 1 and 2A/2B were treated by surgical resection only. Unresectable patients in stage 3 without MNA received either 6 cycles of regimen A or 3 cycles of regimen A plus 3 cycles of regimen C2; regimen A consisted of low doses of cyclophosphamide and vincristine and regimen C consisted of cyclophosphamide, vincristine and pirarubicin before surgical resection. The resectable and unresectable patients were randomly selected to receive post-surgical chemotherapy. The patients with MNA received intensive chemotherapy regimen D2, consisting of cyclophosphamide, vincristine, pirarubicin and cisplatin, and some of them received high-dose chemotherapy with stem cell transplantation.

Results

The 5-year event-free survival (5-EFS) rates of stage 1 and 2A/2B patients without MNA were 97.2 and 89.0% respectively (p = 0.02). A total of 31 patients in stage 3 without MNA received post-surgical chemotherapy, and 30 patients did not. The 5-EFS rates of these two groups (96.0 and 96.2%, respectively) were not significantly different (p = 0.869). The 5-EFS rate for localized patients with MNA (n = 6) was 50.0%, and that of patients without MNA was 95.0% (p < 0.001).

Conclusion

Post-surgical chemotherapy was therefore unnecessary for localized patients without MNA. This treatment strategy using MNA is considered to be appropriate in infants.     

Development of treatment and clinical results in childhood AML in Austria (1993–2013)

Background

Since the early 1990s, three consecutive pediatric acute myeloid leukemia (AML) trials have been performed in Austria (AML-Berlin-Frankfurt-Münster (BFM) 93, AML-BFM 98, and AML-BFM 2004) in close cooperation with the international BFM study center. Herein, we review the pertinent patient characteristics, therapy, and outcome data.

Patients and methods

From January 1993 to April 2013, 249 children and adolescents (193 protocol patients) diagnosed with AML were enrolled in the three BFM studies. Patients were mainly treated in one of five pediatric hematology/oncology centers distributed over Austria.

Results

Many characteristics and outcome parameters were not statistically different between the three trials. Almost similar proportions of patients were stratified into two risk groups: standard risk (SR) (approximately 37?% overall) and high-risk (HR) (61?%). MLL rearrangements were found in 23?% of patients overall as the most frequent genetic aberration subtype. Complete remission (CR) was achieved by 84–95?% of patients. The most important type of event was leukemic relapse (5-year cumulative incidence 40?±?8?%, 21?±?5?%, and 39?±?6?%; p?=?0.058), with a trend to a higher rate specifically in SR patients of study AML-BFM 2004 compared with AML-BFM 98. Importantly, the frequency of death from causes other than relapse sequelae declined over the years (AML-BFM 93: 5/42 12?%, AML-BFM 98: 5/57 9?%, and AML-BFM 2004: 5/94 5?%). Altogether, event-free survival at 5 years varied insignificantly (48?±?8?%, 61?±?7?%, and 50?±?6?%; p?=?0.406). Nevertheless, survival (pSU) apparently improved from BFM 93 to subsequent studies, both overall (57?±?8?%, 75?±?6?%, and 62?±?6?%; p?=?0.046) and regarding the HR group (5-year-probability of survival (pSU) 40?±?10?%, 66?±?8?%, and 52?±?8?%; p?=?0.039).

Conclusion

Treatment of pediatric AML in Austria renders survival rates in the range of international best practice. However, unambiguous statistical comparison of treatment periods is eventually hampered by small numbers and inequalities of recruitment. Hence, only internationally collaborative trials will allow developing treatment further to achieve higher cure rates with fewer events.     

Effect of adjuvant chemoradiotherapy on overall survival of gastric cancer patients submitted to D2 lymphadenectomy

Background

Adjuvant chemoradiotherapy (CRT) is the standard treatment in Western countries for gastric cancer patients submitted to curative resection. However, the role of adjuvant CRT in gastric cancer treated with D2 lymphadenectomy has not been well defined.

Methods

We conducted a retrospective study in patients with stage II to IV gastric adenocarcinoma with no distant metastases, who underwent curative resection with D2 lymphadenectomy between January 2002 and December 2007. The present study compared the 3-year overall survival of two treatments (adjuvant CRT according to the INT 0116 trial versus resection alone). Survival curves were estimated by the Kaplan–Meier method and compared with a log-rank test. Multivariate analysis of prognostic factors was performed by the Cox proportional hazards model.

Results

A total of 185 patients were included, 104 patients (56 %) received adjuvant CRT and 81 received resection alone. The 3-year overall survival was 64.4 % in the CRT group and 61.7 % in the resection-alone group (p: 0.415). However, according to the Cox proportional hazards model, adjuvant CRT was a prognostic factor for 3-year overall survival (hazard ratio [HR] 0.46, 95 % confidence interval [CI] 0.26–0.82, p: 0.008).

Conclusions

In the present study, adjuvant CRT was associated with a lower risk of death over a 3-year period in gastric cancer patients treated with D2 lymphadenectomy.     

Phase II trial of induction irinotecan-cisplatin followed by concurrent irinotecan-cisplatin and radiotherapy for unresectable, locally advanced gastric and oesophageal-gastric junction adenocarcinoma

Purpose

The prognosis of patients with unresectable M0 gastric cancer remains very poor. We performed a phase II trial to explore the efficacy and toxicity of induction irinotecan-cisplatin (IC) followed by concurrent irinotecan-cisplatin and radiotherapy (IC/RT) in this setting.

Methods and materials

Patients with unresectable M0 gastric (GC) or oesophageal-gastric junction (EGJC) adenocarcinomas were treated with two courses of IC (irinotecan, 65?mg/m²; cisplatin, 30?mg/m² on days 1 and 8 every 21?days) followed by IC/RT (daily radiotherapy??45?Gy??with concurrent IC: irinotecan, 65?mg/m², and cisplatin, 30?mg/m², on days 1, 8, 15, and 22). Resectability was reassessed after this treatment, and surgical resection was performed if feasible. The primary endpoint was the R0 resection rate after induction treatment.

Results

Seventeen patients were included in the study (EGJC: 6; GC: 11). An R0 resection was achieved in only 5 patients (29%), and according to the design of the trial (Simon??s optimal two-stage) accrual of patients was terminated after the first stage. No patient died during IC, whereas 3 patients (24%) died during IC/RT and one of 5 resected patients (20%) died during the first 30?days after resection. The median survival was 10.5?months, and the actuarial 2-year survival rate was 27%.

Conclusions

Induction IC followed by IC/RT showed poor efficacy and significant toxicity in patients with unresectable GC/EGJC.     

Tamoxifen plus tegafur-uracil (TUFT) versus tamoxifen plus Adriamycin (doxorubicin) and cyclophosphamide (ACT) as adjuvant therapy to treat node-positive premenopausal breast cancer (PreMBC): results of Japan Clinical Oncology Group Study 9404

Purpose

A prospective randomized clinical trial was conducted to evaluate the efficacy of tamoxifen plus doxorubicin and cyclophosphamide compared to tamoxifen plus tegafur-uracil as an adjuvant therapy to treat node-positive premenopausal breast cancer (PreMBC).

Methods

Eligibility criteria included pathologically node-positive (n = 1–9) preMBC with curative resection, in stages I–IIIA. Patients were randomized to receive either tamoxifen 20 mg/day plus tegafur-uracil 400 mg/day (TU) for 2 years or six courses of a 28-day cycle of doxorubicin 40 mg/m² plus cyclophosphamide 500 mg/m² on day 1 along with tamoxifen (ACT) given for 2 years as adjuvant therapy. Primary endpoint was overall survival (OS), and secondary endpoint was recurrence-free survival (RFS).

Results

In total, 169 patients were recruited (TU arm 87, ACT arm 82) between October 1994 and September 1999. The HR for OS was 0.76 (95 % CI 0.35, 1.66, log-rank p = 0.49) and that for RFS was 0.77 (95 % CI 0.44, 1.36, log-rank p = 0.37), with ACT resulting in a better HR. The 5-year OS was 79.7 % for patients in the TU arm and 83 % for those in the ACT arm. The 5-year RFS was 66.1 % for patients in the TU arm and 70.6 % for those in the ACT arm. A higher proportion of patients in the ACT arm experienced grade 3 leucopenia (0 % in the TU arm, 4 % in the ACT arm).

Conclusions

There were no significant differences in the efficacy of TU and ACT as adjuvant therapy.     

Randomized trial of weekly docetaxel and cisplatin combined with concurrent 3DCRT in patients with locally advanced esophageal cancer

Objective

This randomized controlled clinical study was to assess and compare the efficacy and safety of two chemoradiotherapy regimens [cisplatin + 5-fluorouracil + 3 dimensional conformal radiation therapy (3DCRT) and cisplatin + weekly docetaxel + 3DCRT] in patients with locally advanced esophageal squamous cell carcinoma.

Methods

A total of seventy-four patients with clinical stages IIB to IIIB esophageal squamous cell carcinoma were enrolled. Chemotherapy for PF group comprised 5-fluorouracil at days 1–5 (250 mg/m²/d) and cisplatin (20 mg/m²) at days 1–3 of every 28-day cycle; full treatment course included 2 cycles. Chemotherapy for DP group comprised docetaxel (20 mg/m²) and cisplatin (20 mg/m²) at days 1, 8, 15, 22, 29, and 36. Both groups treated with concurrent 60 Gy 3DCRT at 200 cGy/d.

Results

Seventy-four patients were enrolled and 71 completed the planned treatment, with a follow-up rate of 95.94%. Short-term curative effect was not statistically significant between the two groups (P = 0.471). The 2-year survival rates were 65.7% and 61.1%, respectively (P = 0.806), 5 years survival rates were 34.29% and 27.78%, respectively (P = 0.221), and there was no significant difference by Fisher test (P = 0.734). As common side effects, incidence rates of radioactive esophagitis and hematological toxicity were lower in DP group.

Conclusion

For locally advanced esophageal cancer patients, current chemoradiotherapy with chemotherapy regimen of weekly docetaxel plus cisplatin has equal curative effect with 5-fluorouracil plus cisplatin, but well-tolerated by reducing side effects such as radioactive esophagitis and bone marrow suppression.