Nab-paсlitaxel (Nab-P) in patients with metastatic breast cancer (mBC) with visceral crisis (VC): Efficacy and tolerability.

e12589 Background: Better efficiency and safety of Nab-P is known to be due to the advantages of pharmacokinetics and pharmacodynamics of the drug. The fraction of unbound paclitaxel in plasma is 2.6-fold higher with Nab-P than with P. The purpose of the study was to assess efficacy and safety of Nab-P in ≥2nd lines of chemotherapy (CT) in patients (pts) with mBC with VC. Methods: Inclusion criteria: mBC with VC, ≥ 2 line of CT, HR+, HER2neu+ or triple negative type (TN), normal liver and renal function. Pts received Nab-P 260 mg/m2 q 21 days. Pts with Her2/Neu + received trastuzumab 6 mg/kg q 21 days. Results: 32 mBC pts, mean age 51.34 years (CI 35-76) were included. Among 32 pts Her2/Neu + had 5 (15.6%), TN – 9 (28.1%), HR+ 18(56.3%). 13(40.6%) pts received Nab-P as 2 line of CT, 13 (40.6%) pts, as 3-4 lines, 7(21.9%) as ≥5 lines. Pts were divided into 2 groups: group A - pts with VC 17(53.1%), group B - without VC 15(46.9%). Groups were comparable by age, number of previous CT lines, immunohistochemical types of BC. Group A had 2.47±0.32 CT lines (CV51.83%), including 8(47%) pts, who had received paclitaxel (P) in previous CT lines. Group B had on average 2±0.27 CT lines (CV53.03%). The objective response rate (ORR) was 37.5%(12 pts). In the group A ORR was 35.3% (6 pts). Out of 8 pts with VC, who had received P in previous lines, ORR was achieved in 3 pts (37.5%). In the group B ORR was 33.34%(5 pts). TTP was 6.8 mos (95% CI 6.1-13.7) for all pts, in the group A – 5.7 mos (95% CI 5.9-10.2), in the group B 6 mos (95% CI 6.5-13.7) (p = 0.046). Median 3-year OS of pts in group A was 18.9 mos (95% CI 4.3-22.4), in group B - 22.5 mos (95% CI 8.2-26.7) (p = 0.038). Toxicity did not differ significantly in pts in groups A and B and was manageable. Pts, who previously received P, had no new or severe toxicity. Conclusions: The data obtained confirms the possibility of Nab-P application in pts with VC. The use of Nab-P in pts treated with taxanes in previous lines is supposed for further study.

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Comparative Study Between Clean Intermittent Self-Catheterization (Cisc) and Continuous Indwelling Catheterization (Cidc) in Relieving Acute Refractory Retention of Urine Due to Benign Enlargement of Prostate (Bep)

Bangladesh Journal of Urology ◽

10.3329/bju.v21i2.49882 ◽

2020 ◽

Vol 21 (2) ◽

pp. 105-110

Author(s):

Md Shawkat Alam ◽

Sudip Das Gupta ◽

Hadi Zia Uddin Ahmed ◽

Md Saruar Alam ◽

Sharif Muhammod Wasimuddin

Keyword(s):

Comparative Study ◽

Acute Urinary Retention ◽

Bladder Capacity ◽

Inclusion Criteria ◽

College Hospital ◽

Medical College ◽

High Incidence ◽

Group A ◽

Group B ◽

Better Than

Objective: To compare the clean intermittent self-catheterization (CISC) with continuous indwelling catheterization (CIDC) in relieving acute urinary retention (AUR) due to benign enlargement of prostate (BEP). Materials and Methods :A total 60 patients attending in urology department of Dhaka Medical college hospital were included according to inclusion criteria ,Patients were randomized by lottery into two groups namely group –A and group –B for CISC and IDC drainage respectively . Thus total 60 patients 30 in each group completed study. Results : Most men can safely be managed as out-patients after AUR due to BPH. The degree of mucosal congestion and inflammation within the bladder was found to be lower in those using CISC and the bladder capacity in these patients was also found higher.Patients with an IDC had a high incidence of UTIs then that of patients with CISC. During the period of catheterization the incidence of UTI was 43.3% in group B in comparison to 40% in group A; before TURP 36% in group B in comparison to 10% incidence in group A.According to patient’s opinion CISC is better than IDC in the management of AUR. Experiencing bladder spasm, reporting blood in urine, management difficulties, incidence and severity of pain were less in CISC group, and the method of CISC was well accepted by patients as well as their family members. Conclusion: From the current study it may be suggested that CISC is better technique for management of AUR patient due to BPH than IDC. It can also be very helpful when surgery must be delayed or avoided due to any reasons in this group of patients. Bangladesh Journal of Urology, Vol. 21, No. 2, July 2018 p.105-110

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Gamma Knife surgery as sole treatment for multiple brain metastases: 2-center retrospective review of 1508 cases meeting the inclusion criteria of the JLGK0901 multi-institutional prospective study

Journal of Neurosurgery ◽

10.3171/2010.8.gks10838 ◽

2010 ◽

Vol 113 (Special_Supplement) ◽

pp. 48-52 ◽

Cited By ~ 37

Author(s):

Toru Serizawa ◽

Masaaki Yamamoto ◽

Yasunori Sato ◽

Yoshinori Higuchi ◽

Osamu Nagano ◽

...

Keyword(s):

Brain Metastases ◽

Gamma Knife ◽

Class Ii ◽

Hazard Ratio ◽

Gamma Knife Surgery ◽

Inclusion Criteria ◽

Primary Tumors ◽

Poor Prognostic Factor ◽

Group A ◽

Group B

Object The authors retrospectively reviewed the results of Gamma Knife surgery (GKS) used as the sole treatment for brain metastases in patients who met the eligibility criteria for the ongoing JLGK0901 multi-institutional prospective trial. They also discuss the anticipated results of the JLGK0901 study. Methods Data from 1508 consecutive cases were analyzed. All of the patients were treated at the Gamma Knife House of Chiba Cardiovascular Center or the Mito Gamma House of Katsuta Hospital between 1998 and 2007 and met the following JLGK0901 inclusion criteria: 1) newly diagnosed brain metastases, 2) 1–10 brain lesions, 3) less than 10 cm3 volume of the largest tumor, 4) no more than 15 cm3 total tumor volume, 5) no findings of CSF dissemination, and 6) no impairment of activities of daily living (Karnofsky Performance Scale score < 70) due to extracranial disease. At the initial treatment, all visible lesions were irradiated with GKS without upfront whole-brain radiation therapy. Thereafter, gadolinium-enhanced MR imaging was performed every 2–3 months, and new distant lesions were appropriately retreated with GKS. Patients were divided into groups according to numbers of tumors: Group A, single lesions (565 cases); Group B, 2–4 tumors (577 cases); and Group C, 5–10 tumors (366 cases). The differences in overall survival (OS) were compared between groups. Results The median age of the patients was 66 years (range 19–96 years). There were 963 men and 545 women. The primary tumors were in the lung in 1114 patients, gastrointestinal tract in 179, breast in 105, urinary tract in 66, and other sites in 44. The overall mean survival time was 0.78 years (0.99 years for Group A, 0.68 years for Group B, and 0.62 years for Group C). The differences between Groups A and B (p < 0.0001) and between Groups B and C (p = 0.0312) were statistically significant. Multivariate analysis revealed significant prognostic factors for OS to be sex (poor prognostic factor: male, p < 0.0001), recursive partitioning analysis class (Class I vs Class II and Class II vs III, both p < 0.0001), primary site (lung vs breast, p = 0.0047), and number of tumors (Group A vs Group B, p < 0.0001). However, no statistically difference was detected between Groups B and C (p = 0.1027, hazard ratio 1.124, 95% CI 0.999–1.265). Conclusions The results of this retrospective analysis revealed an upper CI of 1.265 for the hazard ratio, which was lower than the 1.3 initially set by the JLGK0901 study. The JLGK0901 study is anticipated to show noninferiority of GKS as sole treatment for patients with 5–10 brain metastases compared with those with 2–4 in terms of OS.

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A comparative clinical study to access the role of Basti and Virechana Karma followed by Rasayana in post menopausal Asthikshaya (Osteoporosis)

Journal of Ayurveda and Integrated Medical Sciences (JAIMS) ◽

10.21760/jaims.5.5.12 ◽

2020 ◽

Vol 5 (05) ◽

pp. 96-103

Author(s):

Deepa S. Patil ◽

Prashanth A.S

Keyword(s):

Clinical Study ◽

Inclusion Criteria ◽

Comparative Clinical Study ◽

Group A ◽

Post Menopausal ◽

Group B

Rajonivrutti condition manifests in the end phase of Jarawastha; but its Samprapti begins from the Sandhikala of Madhyamawastha and Jarawastha due to Vatavruddi in womens reaching Rajonivrutti. Postmenopausal Asthikshaya is a disabling disease, which renders women a bedridden life. Here 40 subjects diagnosed with postmenopausal Asthikshaya fulfilling the inclusion criteria were selected for the study and randomly categorized intp two groups as group A and group B each consisting of 20 subjects. Group A received Amapachana with Hinguvachadivati, Yastimadhu Siddha Ksheerabasti administered in Yoga Basti schedule followed by Tritiyatriphala Rasayana. Group B received Amapachana with Hinguvachadivati, Sadhyosnehapana with Amrita Ghrita, Sarvanga Abyanga with Murchita Tilataila followed by Sarvanga Swedana and Sneha Virechana was admistered with Eranda Taila followed by Tritiyatriphala Rasayana was given. Tritiya Triphala Rasayana selected for the present study by adapting all the general principles of prevention and management of Asthikshaya and as it is a well known Rasayana.

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Effect of Virechana Karma along with Guggulu Kalpanas in the management of Medoroga - A Double Arm Study

Journal of Ayurveda and Integrated Medical Sciences (JAIMS) ◽

10.21760/jaims.5.5.11 ◽

2020 ◽

Vol 5 (05) ◽

pp. 89-95

Author(s):

Pooja Abhrange ◽

S. G. Chavan ◽

Prashanth A.S.

Keyword(s):

Metabolic Disease ◽

Prime Factor ◽

Natural Process ◽

The Body ◽

Inclusion Criteria ◽

Contributing Factors ◽

Root Cause ◽

Individual Person ◽

Group A ◽

Group B

Metabolism is the natural process of the body, which is necessary to maintenance of the homeostasis of an individual person. Everybody constitutions are always in the process of metabolism, which is a combination of Anabolism (Construction) and Catabolism (Deterioration). As Agni is prime factor for all the Chayapachayakriya. Medoroga, is one of the Metabolic disease, in which contributing factors are Agni, Ama along with Kaphapradhana Tridosha, Medodhathu. Due to various types of etiological factors, the Agni in the body gets vitiated and Jatharagnimandya occurs. By this Jatharagnimandya, Dhathuparinama will not occur properly. This will lead to Medoroga and further many other Upadravas. To correct these conditions, Ayurveda has many modes of therapies like Samshodhana, Samshamana. By these we can correct the metabolism from the root cause. Here 40 Subjects diagnosed with Medoroga w.s.r. to Hyperlipidemia fulfilling the Inclusion criteria were selected for study and randomly categorized into two groups as Group A and Group B each consisting of 20 subjects. For both groups Amapachana with Chitrakadi Vati, Sadhyosnehapana with Murchita Sarshapa Taila, Sarvanga Abhyanga with Murchita Tila Taila followed by Swedana. And Virechana was administered with Virechana Gulika. Than each group received two different Shamanoushadhi. So, the objective of the study is to establish the efficacy of Virechana along with Dashanga Guggulu and Virechana along with Shadushana Guggulu in the management of Medoroga.

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The association of renal function with safety and efficacy of cisplatin plus S-1 (CS) therapy and docetaxel plus cisplatin plus S-1 (DCS) therapy in patients with advanced gastric cancer (AGC): An additional analysis of JCOG1013.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.e16035 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. e16035-e16035

Author(s):

Shuichi Hironaka ◽

Ryo Sadachi ◽

Nozomu Machida ◽

Satoru Iwasa ◽

Yasuhide Yamada ◽

...

Keyword(s):

Renal Function ◽

Adverse Events ◽

Objective Response ◽

Exploratory Analysis ◽

Phase Iii ◽

Fixed Dose ◽

Hematological Toxicity ◽

Significant Difference ◽

Group A ◽

Group B

e16035 Background: A phase III study, JCOG1013, did not show the superiority of docetaxel plus cisplatin plus S-1 (DCS) to cisplatin plus S-1 (CS) in overall survival (OS) (Yamada Y, Lancet GH 2019). It is known that cisplatin and gimeracil (an inhibitor of dihydropyrimidine dehydrogenase contained in S-1) are excreted in urine. We previously reported (abstr 197, ASCO-GI 2021) exploratory analysis of JCOG1013 which showed creatinine clearance (CrCl) was associated with safety (Grade [G]4 hematological toxicity for CS, and G3-4 non-hematological toxicity for CS and DCS), but not with efficacy in either group. Here, we report the additional detail results of this exploratory analysis. Methods: Among 741 participants in JCOG1013, patients with serum creatinine level < 1.2 mg/dL were included in this analysis and categorized by CrCl and treatment into A1 (CrCl ≥ 80 mL/min, CS), A2 (60 < CrCl < 80, CS), A3 (CrCl < 60, CS), B1 (CrCl > 80, DCS), B2 (60 < CrCl < 80, DCS), and B3 (CrCl < 60, DCS). The dose (mg/m2) of C/S was 60/80 regardless renal function in group A (A1, A2 and A3), and that of D/C/S was adjusted in group B as follows: 40/60/80 in B1, 40/50/80 in B2, and 40/40/65 in B3. Adverse events, OS, progression-free survival (PFS), and objective response rate (ORR) were compared by CrCl in group A (A1 vs. A2 vs. A3) and group B (B1 vs B2 vs B3), respectively. Results: Of 723 pts (169/136/57 in A1/A2/A3 and 170/138/53 in B1/B2/B3), the median CrCl (mL/min) was 94.1/71.9/53.4 in A1/A2/A3 and 98.2/70.0/55.6 in B1/B2/B3. The relative dose intensity of C/S was 90.4/75.3%, 87.8/74.9% and 85.7/72.8% in A1, A2 and A3, and that of D/C/S was 87.5/77.7/74.9%, 85.8/61.2/72.7% and 87.8/49.4/58.3% in B1, B2 and B3. The incidence of G4 white blood cell decreased, G4 neutrophil count decreased, and G3-4 anorexia were 1.2/4.4/9.3% (P < 0.01), 4.8/11.1/18.5% (P < 0.01), 14.4/28.1/28.6% (P < 0.01) in A1/A2/A3, and 1.8/3.0/4.0% (P = 0.36), 27.3/24.8/20.0% (P = 0.28), 22.4/29.3/32.0% (P = 0.11) in B1/B2/B3, respectively. No significant association between CrCl and other adverse events was observed either in CS or in DCS group. The median OS was 15.4/15.5/15.4 months in A1/A2/A3 (P = 0.89) and 15.3/13.7/13.7 months in B1/B2/B3 (P = 0.72). The median PFS was comparable among A1/A2/A3 (7.1/6.8/6.2 months, P = 0.88) and B1/B2/B3 groups (7.5/7.2/7.8 months, P = 0.85). ORR showed no significant difference in A1/A2/A3 (58.9/57.8/46.9%, P = 0.31) and B1/B2/B3 groups (62.0/61.5/51.5%, P = 0.36). Conclusions: Dose modification according to renal function in the DCS arm could control the increase of severe toxicities, which were observed frequently in patients with low renal function in patients receiving fixed dose of CS. Clinical trial information: 000007652.

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Cisplatin and VP16 in Metastatic Breast Carcinoma as a Third-Line Chemotherapy: A Randomized Study Comparing Low versus High Doses of Cisplatin

Tumori Journal ◽

10.1177/030089169508100405 ◽

1995 ◽

Vol 81 (4) ◽

pp. 241-244 ◽

Cited By ~ 11

Author(s):

Guido Ceci ◽

Giancarlo Bisagni ◽

Giorgio Cocconi ◽

Carmelina Rodinò ◽

Virginio Belsanti ◽

...

Keyword(s):

Breast Cancer ◽

Advanced Breast Cancer ◽

Low Dose ◽

Objective Response ◽

Metastatic Breast ◽

Advanced Breast ◽

High Dose ◽

Severe Toxicity ◽

Third Line ◽

Line Chemotherapy

Aims and background The study was designed to define the activity of the combination of cisplatin and etoposide as third-line chemotherapy for advanced breast cancer and to investigate the role of the dosage of cisplatin on the effectiveness of the combination. Methods Ninety-five eligible patients with advanced breast cancer who had failed or relapsed on two previous lines of chemotherapy were randomized to receive cisplatin at a high dose (100 mg/m2 i.v. day 1, arm A) or a low dose (60 mg/m2 day 1, arm B), combined with etoposide (100 mg/m2 i.v. days 4, 6 and 8). Cycles were repeated every 3 weeks. Results Of the 78 patients evaluable for response (39 in arm A and 39 in arm B), 9 (12%) showed complete or partial response, 5 (13%) in the high-dose arm and 4 (10%) in the low-dose arm. One complete response was seen in the high-dose arm and none in the low-dose arm. The only 2 patients with brain involvement showed an objective response (one CR in arm A and one PR in arm B). Median time to progression was 14 weeks in arm A and 10 weeks in arm B, median duration of remission 28 and 34 weeks, and survival 36 and 35 weeks, respectively. The differences were not significant. As expected, the patients in the high-dose arm experienced more severe toxicity. One toxic death was observed in each arm due to sepsis in agranulocytosis. The difference was statistically significant regarding nausea and vomiting. Neurotoxicity and ototoxicity were not relevant problems in this patient setting. Conclusions Considering the very poor prognostic factors presented by these patients, the combination showed a certain activity, and further evaluation in earlier stages of disease is warranted. A particular responsiveness on brain metastases is suggested. The dose of cisplatin was not proven to be of significant importance.

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Variable use of amiodarone is associated with a greater risk of recurrence of atrial fibrillation in the critically ill

QJM ◽

10.1093/qjmed/hcaa039.025 ◽

2020 ◽

Vol 113 (Supplement_1) ◽

Author(s):

N A Fahmy ◽

S M Alfawal ◽

H S Abdelsamie ◽

A M Hassan

Keyword(s):

Atrial Fibrillation ◽

Prospective Observational Study ◽

P Value ◽

Loading Dose ◽

Inclusion Criteria ◽

Reactive Protein ◽

Group A ◽

Group B ◽

Af Recurrence ◽

New Onset

Abstract Background Atrial fibrillation (AF) is the most common sustained arrhythmia affecting humans. It is an electrical disturbance that leads to rapid, disorganized, and asynchronous contraction of the atrial muscle. In clinical practice, it accounts for approximately one-third of hospitalizations for cardiac rhythm disturbances. The incidence of AF increases from less than 0.1% per year in those under 40 years old to exceed 1.5% per year in women and 2% per year in men older than 80 years. Aim of the Work: to discuss the effect of variation in amiodarone use (including dosage and duration) on dysrhythmia recurrence in patients with new-onset AF in ICU. Patients and Methods This was a prospective observational study conducted over 6 months, 60 patients who fulfilled inclusion criteria were included in the study divided in two groups according to amiodarone dosage, each group is 30 patients: Group (A): received a loading dose of amiodarone followed by an infusion (1200mg amiodarone). Group (B): received a loading dose of amiodarone not followed by an infusion (300mg amiodarone). Results a significant positive correlation was observed between level of C-reactive protein (CRP) and the rate of AF recurrence. As regard effect of CRP on AF recurrence; in AF recurrent patients, mean is (191±77.3) with range from 15 to 352 which significantly differed from Non-recurrent AF patients, mean is (89±63) with range from 20 to 223 (p value <0.001). AF recurrence was higher in group (B) than group (A),. In group (A) 8 patients had recurrent AF representing 26.7 % and in group (B) 19 patients had AF recurrence representing 63.3% (p value =0.004). Conclusion Patients with new-onset AF in (ICU) who are treated with amiodarone should receive a loading dose, immediately followed by an infusion.

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Morphology of Right Atrioventricular Valve -A Postmortem Study

Medicine Today ◽

10.3329/medtoday.v32i1.44830 ◽

2020 ◽

Vol 32 (1) ◽

pp. 42-44

Author(s):

Mahmuda Sultana ◽

Md Tazul Islam ◽

Pran Krishna Basak ◽

Md Samir Uddin ◽

Zakia Sultana

Keyword(s):

Human Heart ◽

Heart Valves ◽

Age Group ◽

Atrioventricular Valve ◽

Inclusion Criteria ◽

Mitral Valves ◽

Medical College ◽

Group A ◽

Medicine Today ◽

Group B

Introduction: Heart valves serve the important function of preventing backflow, or regurgitation, in the healthy heart. It is well known that cardiac valves can suffer from congenital and acquired disease. Most frequent acquired valvular abnormalities are stenoses of the aortic and mitral valves, which account for approximately 2/3rd of all valve disease. For the management of valvular disease morphology of right atrioventricular valve is essential. Materials and Methods: Study design was descriptive type of study. Place and period of study was Department of Anatomy, Sylhet MAG Osmani Medical College, Sylhet from July 2015 to June 2016. Results: Present study was performed on 70 post mortem human hearts of age ranging from 9 to 70 years. Human heart was collected from the unclaimed dead bodies autopsied in the department of Forensic medicine in Sylhet MAG Osmani Medical College during the study period fulfilling the inclusion criteria. Conclusion: The collected samples were divided into 3 groups depending on age. Group – A: (9 - 21 Years), Group - B: (22 - 41 Years), Group - C: ( 42 -70) Years. Each group was subdivided into two groups depending on their sex. Medicine Today 2020 Vol.32(1): 42-44

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Vinorelbine as first-line chemotherapy for metastatic breast carcinoma.

Journal of Clinical Oncology ◽

10.1200/jco.1994.12.2.336 ◽

1994 ◽

Vol 12 (2) ◽

pp. 336-341 ◽

Cited By ~ 128

Author(s):

A Romero ◽

M G Rabinovich ◽

C T Vallejo ◽

J E Perez ◽

R Rodriguez ◽

...

Keyword(s):

Breast Cancer ◽

Metastatic Breast Cancer ◽

Breast Carcinoma ◽

Objective Response ◽

Metastatic Breast ◽

Survival Duration ◽

Severe Toxicity ◽

First Line ◽

Metastatic Breast Carcinoma ◽

Line Chemotherapy

PURPOSE A phase II trial was performed to evaluate the efficacy and toxicity of vinorelbine (VNB) as first-line chemotherapy for metastatic breast carcinoma. PATIENTS AND METHODS Between August 1991 and February 1993, 45 patients with metastatic breast cancer were entered onto the study. Therapy consisted of VNB 30 mg/m2 diluted in 500 mL of normal saline administered as a 1-hour intravenous infusion. Injections were repeated weekly until evidence of progressive disease (PD) or severe toxicity developed. RESULTS One patient was considered not assessable for response. An objective response (OR) was observed in 18 of 44 patients (41%; 95% confidence interval, 26% to 56%). Three patients (7%) had a complete response (CR) and 15 (34%) had a partial response (PR). The median time to treatment failure for the entire group was 6 months (range, 1 to 15), and the median duration of response was 9 months (range, 1 to 15). The median survival duration has not been reached yet. There were no treatment-related deaths. The dose-limiting toxicity was myelosuppression. Leukopenia occurred in 35 patients (78%) and was grade 3 or 4 in 16 (36%). Phlebitis was observed in 19 of 29 patients (66%) who did not have central implantable venous systems. Fifteen patients (33%) developed peripheral neurotoxicity. Myalgia occurred in 20 patients (44%). CONCLUSION VNB is an active drug against metastatic breast cancer with moderate toxicity, which justifies further evaluation in association with other agents.

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Retrospective analysis of first-line chemotherapy in 132 patients with advanced small-bowel adenocarcinoma.

Journal of Clinical Oncology ◽

10.1200/jco.2011.29.4_suppl.260 ◽

2011 ◽

Vol 29 (4_suppl) ◽

pp. 260-260

Author(s):

T. Tsushima ◽

N. Boku ◽

Y. Honma ◽

H. Takahashi ◽

S. Ueda ◽

...

Keyword(s):

Small Bowel ◽

Univariate Analysis ◽

Objective Response ◽

Progression Free Survival ◽

Ampullary Carcinoma ◽

Small Bowel Adenocarcinoma ◽

Kaplan Meier ◽

Group A ◽

Group B ◽

Ecog Ps

260 Background: No standard care has been established for advanced small-bowel adenocarcinoma (SBA). The aim of this study is to explore a most promising chemotherapy regimen for advanced SBA. Methods: All data were collected from medical records of patients with advanced or recurrent SBA who received chemotherapy between April 1999 and March 2009 at 41 hospitals in Japan. Selection criteria were as follows: 1) histologically proven SBA, excluding ampullary carcinoma, 2) no previous chemotherapy or radiotherapy, 3) ECOG PS 0-2, 4) adequate bone marrow, hepatic and renal functions, 5) no concomitant malignancy. Patients were divided into the five groups by regimens: group A, fluoropyrimidine alone; group B, fluoropyrimidine + cisplatin; group C, fluoropyrimidine + oxaliplatin; group D, fluoropyrimidine + irinotecan; group E, others. Progression-free survival (PFS) and overall survival (OS) were calculated by Kaplan-Meier method. Results: Demographics of selected 132 patients were: median age (range), 59 (23-78) years; male/female, 87/45; location of primary tumor, duodenum/jejunum/ileum/unknown, 80/32/17/3; advanced/recurrent disease, 91/41. The numbers of the patients in group A, B, C, D and E were 60, 17, 22, 11 and 22, and objective response rates (ORR) in the patients with target lesions were 20% (9/46), 38% (5/13), 42% (8/19), 25% (2/8), 21% (4/19), respectively. Median PFS and OS were 6.0 and 14.0 months for the whole population, and those in each group are shown in the Table.In comparison with fluoropyrimidine alone (A), oxaliplatin-combined regimens (C) associated with better PFS (HR=0.53 [0.31-0.93], p=0.03) and OS (HR=0.64 [0.33-1.25], p=0.19), while cisplatin-combined regimens (B) did not (HR=1.54 [0.88-2.68], p=0.13 for PFS and HR=1.67 [0.94-2.97], p=0.08 for OS) by univariate analysis. Conclusions: It is suggested that oxaliplatin-combined regimens might be the most promising regimen for advanced SBA. [Table: see text] No significant financial relationships to disclose.

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