Efficacy and safety of gemcitabine-oxaliplatin combined with huachansu in patients with advanced gallbladder carcinoma

AIM： To evaluate the efficacy and safety of gemcitabine-oxaliplatin （GEMOX） combined with huachansu （cinobufagin） injection treatment in patients with locally advanced or metastatic gallbladder carcinoma （GBC）, and to assess the quality of life （QOL） of such patients. METHODS： Twenty-fi ve patients with locally advanced or metastatic GBC were treated with intravenous gemcitabine （1000 mg/m^2） over 30 min on days 1 and 8, 2 h infusion of oxaliplatin （120 mg/m^2） on day 1, and 2-3 h infusion of huachansu （20 mL/m^2） on days -3-11, every 3-4 wk. Treatment was continued until occurrence of unacceptable toxicity or disease progression. QOL of patients was assessed by the EORTC QLQ-C30 at baseline, at the end of the fi rst, third and sixth chemotherapy cycles, and 1 mo after the treatment. RESULTS： Among the 25 patients with a median age of 64 years （range 42-78 years）, 23 were evaluable in the study. A total of 137 cycles of therapy were performed and the median cycle was 5 （range 1-8） per patient. Out of the 23 patients whose response couldbe evaluated, 8 partial responses （PR） were observed （34.8%）, while 7 patients （30.4%） demonstrated a stable disease （SD）. The disease control rate was 65.2%. Progression of cancer was observed in 8 （34.8%） patients. The median progression-free and overall survival time was 5.8 mo （95% CI： 4.5-7.1 mo） and 10.5 mo, respectively. The therapy was well tolerated, with moderate myelosuppression as the main toxicity. Anemia grade 2 was seen in 16.0%, neutropenia grade 3 in 8.0% and thrombocytopenia grade 3 in 24.0% of patients, respectively. Non-hematologic toxicity ranged from mild to moderate. No death occurred due to toxicity. The QOL of patients was improved after chemotherapy, and the scores of QOL were increased by 10 to 20 points. CONCLUSION： GEMOX combined with huachansu （cinobufagin） injection is well tolerated, effective, thus improving the QOL of patients with advanced GBC.     

Stereotactic body radiotherapy using CyberKnife for locally advanced unresectable and metastatic pancreatic cancer

AIM: To evaluate the efficacy and toxicity of stereotactic body radiotherapy using CyberKnife for locally advanced unresectable and metastatic pancreatic cancer.METHODS: From June 2010 to May 2014, 25 patients with locally advanced unresectable and metastatic pancreatic cancer underwent stereotactic body radiotherapy. Nine patients presented with unresectable locally advanced disease and 16 had metastatic disease. Primary end-points of this study were overall survival, relief of abdominal pain, and toxicity.RESULTS: Fourteen patients were treated with a total dose of 30-36 Gy in three fractions and the remainder with 40-48 Gy in four fractions. Median follow-up was 11 mo (range: 2-25 mo). The median survival duration calculated from the time of stereotactic body radiotherapy for the entire group, the locally advanced group, and the metastatic group was 9.0 mo, 13.5 mo, and 8.5 mo, respectively. Overall survival was 37% and 18% at one and two years, respectively. Abdominal pain relief was achieved within 2 wk of completing radiotherapy in the patients who received successful palliation (13 of 20 patients had significant pain). Five patients (20%) had grade 1 nausea, and one (4%) had grade 2 nausea. No acute grade 3+ toxicity was seen.CONCLUSION: Stereotactic body radiotherapy using the CyberKnife system is a promising, noninvasive, palliative treatment with acceptable toxicity for locally advanced unresectable and metastatic pancreatic cancer.     

A Multicenter Phase II Trial of Gemcitabine Plus Oxaliplatin in Unresectable Gallbladder Cancer

Background/Aims

No standard chemotherapy has been established for advanced gallbladder cancer. The authors studied the activity and tolerability of a gemcitabine and oxaliplatin (GEMOX) combination in unresectable gallbladder cancer (GBC).

Methods

Adult patients with pathologically confirmed unresectable GBC were prospectively recruited at three centers. No patient had received prior chemotherapy or radiotherapy. Patients received cycles of gemcitabine at 1,000 mg/m² on day 1, followed by oxaliplatin at 100 mg/m² on day 2, every 2 weeks. The primary study endpoint was time to progression.

Results

Forty patients with unresectable GBC were enrolled. The median age was 60 years (range, 38 to 79 years). All patients showed good performance status. Of the 33 analyzable patients, 12 achieved partial response (36%), 17 stable disease (52%), and four progressive disease (12%). No patient achieved a complete response. The tumor control rate was 88%. At a median follow-up of 6.8 months, the median time to progression was 5.3 months (95% confidence interval [CI], 3.7 to 6.9), and median overall survival was 6.8 months (95% CI, 6.1 to 7.5). Nine of the 40 patients (23%) experienced at least a grade-3 adverse event, but no patient experienced a grade-4 adverse event.

Conclusions

GEMOX combination therapy is a feasible option and is well tolerated in unresectable GBC.     

Multicenter cooperative observational study of idiopathic pulmonary fibrosis with non-small cell lung cancer

AIM: To research the natural course of idiopathic pulmonary fibrosis (IPF) with advanced non-small cell lung cancer (NSCLC) and the association between acute exacerbation (AE) of IPF and chemotherapy (CT). METHODS: From May 2007 through April 2011, 17 CT naive patients with IPF and advanced NSCLC were enrolled. Patients were classified into best supportive care (BSC) group or CT group based on the patient’s preference. Patients in the CT group received carboplatin (CBDCA) (AUC 5-6) plus paclitaxel (PTX) (175-200 mg/m²) on day 1 of each 21-d cycle as first-line therapy. RESULTS: All patients but one chose the CT group. In the CT group, the objective response rate was 38%. The most frequent toxicity ≥ grade 3 was neutropenia (88%). Two patients (12.5%) developed AE-IPF. The median progression-free survival, the median survival time and the 1-year survival rate were 4.1 mo, 8.7 mo and 35%, respectively. Second-line CT-related AE and CT-unrelated AE occurred in 2 and 3 patients (1: BSC group; 2: CT group), respectively. Seven (41%) of all patients developed AE-IPF throughout the clinical course, and 6 of 7 patients with AE-IPF died within one month. CONCLUSION: The incidence of AE-IPF was higher among IPF patients with advanced NSCLC than among those without NSCLC. CBDCA plus PTX regimen was tolerable and effective. However, AE-IPF has a fatal toxicity with or without CT in IPF patients with advanced NSCLC.     

Gemcitabine in elderly patients with advanced pancreatic cancer

AIM:To assess feasibility,tolerability and efficacy of gemcitabine-based chemotherapy in patients≥75 years old with advanced pancreatic cancer.METHODS:All consecutive patients≥75 years old with advanced pancreatic adenocarcinoma were included in this retrospective study.Necessary criteria to receive chemotherapy were:performance status 0-2,adequate biological parameters and no serious comorbidities.Other patients received best supportive care(BSC).RESULTS:Thirty-eight patients(53%women,median age 78 years,r...     

Capecitabine and irinotecan with and without bevacizumab for advanced colorectal cancer patients

AIM： To investigate the efficacy and safety of cape- citabine plus irinotecan ＋ bevacizumab in advanced or metastatic colorectal cancer patients. METHODS： Forty six patients with previously untreated, locally-advanced or metastatic colorectal cancer （mCRC） were recruited between 2001-2006 in a pro- spective open-label phase Ⅱ trial, in German commu- nity-based outpatient clinics. Patients received a stan- dard capecitabine plus irinotecan （CAPIRI） or CAPIRI plus bevacizumab （CAPIRI-BEV） regimen every 3 wk. Dose reductions were mandatory from the first cycle in cases of 〉 grade 2 toxicity. The treatment choice of bevacizumab was at the discretion of the physician. The primary endpoints were response and toxicity and sec- ondary endpoints included progression-free survival and overall survival. RESULTS： In the CAPIRI group vs the CAPRI-Bev group there were more female than male patients （47% vs 24%）, and more patients had colon as the primary tumor site （58.8% vs 48.2%） with fewer patients having sigmoid colon as primary tumor site （5.9% vs 20.7%）. Grade 3/4 toxicity was higher with CAPIRI than CAPIRI-Bev： 82% vs 58.6%. Partial response rates were 29.4% and 34.5%, and tumor control rates were 70.6% and 75.9%, respectively. No complete re- sponses were observed. The median progression-free survival was 11.4 mo and 12.8 mo for CAPIRI and CA- PIRI-Bev, respectively. The median overall survival for CAPIRI was 15 mo （458 d） and for CAPIRI-Bev 24 mo （733 d）. These differences were not statistically different. In the CAPIRI-Bev, group, two patients under- went a full secondary tumor resection after treatment, whereas in the CAPIRI group no cases underwent this procedure. CONCLUSION： Both regimens were well tolerated and offered effective tumor growth control in this out- patient setting. Severe gastrointestinal toxicities and thromboembolic events were rare and if observed were never fatal.     

Second-line therapy for gemcitabine-pretreated advanced or metastatic pancreatic cancer

AIM: To investigate second-line chemotherapy in gemcitabine-pretreated patients with advanced or metastatic pancreatic cancer [(frequency, response, outcome, course of carbohydrate antigen 19-9 (CA 19-9)].METHODS: This retrospective study included all patients with advanced or metastatic pancreatic cancer (adenocarcinoma or carcinoma) treated with second-line chemotherapy in our center between 2000 and 2008. All patients received first-line chemotherapy with gemcitabine, and prior surgery or radiotherapy was permitted. We analyzed each chemotherapy protocol for second-line treatment, the number of cycles and the type of combination used. The primary endpoint was overall survival. Secondary endpoints included progression-free survival, response rate, grade 3-4 toxicity, dosage modifications and CA 19-9 course.RESULTS: A total of eighty patients (38%) underwent a second-line therapy among 206 patients who had initially received first-line treatment with a gemcitabine-based regimen. Median number of cycles was 4 (range: 1-12) and the median duration of treatment was 2.6 mo (range: 0.3-7.4). The overall disease control rate was 40.0%. The median overall survival and progression-free survival from the start of second-line therapy were 5.8 (95% CI: 4.1-6.6) and 3.4 mo (95% CI: 2.4-4.2), respectively. Toxicity was generally acceptable. Median overall survival of patients with a CA 19-9 level declining by more than 20% was 10.3 mo (95% CI: 4.5-11.6) vs 5.2 mo (95% CI: 4.0-6.4) for others (P = 0.008).CONCLUSION: A large proportion of patients could benefit from second-line therapy, and CA 19-9 allows efficient treatment monitoring both in first and second-line chemotherapy.     

Phase II-trial of tirapazamine in combination with cisplatin and gemcitabine in patients with advanced non-small-cell-lung-cancer (NSCLC)

Despite improvements in chemotherapy of advanced and metastatic Non-Small-Cell-Lung-Cancer (NSCLC) the prognosis of these patients still remains poor with a 5-year-survival of 2 to 5 %. Due to the high level of hypoxic cells in solid tumors agents with activity in hypoxic milieu as the Benzotriazine compound Tirapazamine (SR 259 075) might improve the therapeutic results. We treated 45 patients with advanced or metastatic Non-Small-Cell-Lung-Cancer (stage IIIb: 20 patients, stage IV: 25 patients) with the combination TPZ 330 mg/m (2) (day 1), Cisplatin 75 mg/m (2) (day 1) and Gemcitabine 1250 mg/m (2) (day 1 and 8) every 3 weeks. With a response rate of 40 % median progression free survival was 6.7 months (4.8 - 8.1 months) and median survival was 8.1 months (7.5 - 12.5 months), (1-year-survival: 35 %). Hematologic and non-hematologic toxicity was moderate (neutropenia CTC grade 3 and 4: 20 %, thrombocytopenia CTC grade 3 and 4: 16 %, nausea and vomiting CTC 3: 5 %). Treatment of advanced and metastatic NSCLC with TPZ in combination with Gemcitabine/Cisplatin was well feasible and showed results recording to currently published data. The results of a following phase III-trial are awaited.     

支气管动脉灌注联合全身化疗治疗晚期非小细胞肺癌

目的观察选择性支气管动脉灌注吉西他滨、奥沙利铂（GEMOX方案）并联合吉西他滨静脉滴注化疗治疗晚期非小细胞肺癌（NSCLC）的疗效和不良反应。方法对38例晚期NSCLC患者第1 d经支气管动脉注入吉西他滨、奥沙利铂,第8 d予吉西他滨静脉滴注化疗,21~28 d为一个周期,完成2~3周期后评价其疗效及不良反应。结果 38例中完全缓解（CR）0例,部分缓解（PR）23例,总有效率60.5%。主要不良反应为骨髓抑制、消化道反应等,不良反应多为Ⅰ~Ⅱ度。结论基于GE-MOX方案的支气管动脉灌注联合全身化疗治疗晚期非小细胞肺癌疗效好、不良反应可耐受。     

Weekly paclitaxel for advanced non-small cell lung cancer patients not suitable for platinum-based therapy

Platinum-based combinations are efficacious in the treatment of advanced non-small cell lung cancer (NSCLC) but their toxicity makes them unsuitable for elderly and for patients with co-morbidities. We assessed the efficacy and toxicity of low-dose of paclitaxel in patients who were elderly or who had contraindications against cisplatin therapy. Seventy-one patients (median age 68; range 42-82 years) with unresectable NSCLC were treated with weekly paclitaxel (80 mg/m2) infusion (1 h) for several cycles without intervening rest periods. Thirty-seven patients had PS 1 and 34 had PS 2 status. A total of 614 courses were administered (median 9, range 2-20). There were no episodes of grade 4 toxicities and only 1 patient had grade 3 thrombopenia. Grade 3 anemia or neutropenia were not observed and severe non-hematological toxicity was uncommon: grade 1-2 fatigue in 52%; grade 1-2 motor neuropathy in 42% and grade 3 in 5.5%; grade 1-2 sensory neuropathy in 46.3% of patients. Twenty-seven of the 67 evaluable patients (40.3%) had an objective response, whereas 26 patients (38.8%) had stable disease. The median overall survival for the entire group was 8.4 months (95% CI = 5.6 to 11.2) and the 1-year and 2-year survival was 37.4% and 12.1%, respectively. The median time-to-progression was 5.4 months (95% CI = 3.3 to 7.4). Our data show that low-dose weekly paclitaxel is active and well tolerated in this group of patients with NSCLC and poor prognosis and, as such, is useful for patients in whom platinum-based combinations are not suitable.     

Intensity-modulated radiation therapy with concurrent chemotherapy for locally advanced cervical and upper thoracic esophageal cancer

INTRODUCTION Cervical esophageal cancer occurs rarely and accounts for only 2%-10% of all esophageal carcinomas in the United States[1]. Surgery, an option only for patients with early-stage tumors, generally requires a total laryngopha ryngoesophagectomy…     

The prognosis after curative resection of gallbladder cancer with hilar invasion is similar to that of hilar cholangiocarcinoma

Background/purpose

Gallbladder cancer (GBC) often invades the hepatic hilum and even small tumors can cause obstructive jaundice. Operative intervention for GBC with obstructive jaundice is sometimes not recommended because it is associated with a poor prognosis. However, the extended procedure is recommended for patients with hilar cholangiocarcinoma (HC). We therefore compared the postoperative survival of patients with GBC invading the hepatic hilum with that with HC.

Methods

Between 1998 and 2008, 27 patients with GBC invasion of the hepatic hilum (hGBC) and 124 with HC underwent surgical resection with curative intent in the Department of Surgical Oncology, Hokkaido University Graduate School of Medicine. This study included patients with GBC without peritoneal dissemination and liver or para-aortic lymph node metastasis. Extended right hemihepatectomy and extrahepatic bile duct resection comprise the treatment of choice for GBC with hilar invasion (hGBC). We aimed to achieve R0 outcomes by aggressive vascular resection and/or concomitant resection of directly invaded organs around the GBC along with extended right hemihepatectomy.

Results

We analyzed 27 patients with hGBC (age 58?C83?years; median 71?years; male:female 13:14) and 124 with HC (age 45?C80?years; median 69?years; male:female 94:30). The 3- and 5-year survival rates of 43 and 24% for hGBC and 58 and 38% for HC, respectively, did not differ significantly (p?=?0.14). Preoperative obstructive jaundice was a complication in 22 (81%) and 95 (77%) patients with hGBC and HC, respectively. The 5-year survival rates were 40 and 36%, respectively, which did not differ significantly (p?=?0.61). The 5-year survival rates after extended right hemihepatectomy to resect the tumor with curative intent were 34 and 34% for hGBC and HC, which did not differ significantly (p?=?0.14).

Conclusions

The prognosis after curative resection of GBC with hilar invasion is similar to that of HC in selected patients. Aggressive surgery for advanced GBC with hilar invasion might increase survival rates.     

Activity and safety of pegylated liposomal doxorubicin, 5-fluorouracil and folinic acid in inoperable hepatocellular carcinoma： A phase Ⅱ study

AIM: To improve the results of New therapeutic strategies in hepatocellular carcinoma (HCC). We have conducted a phase Ⅱ study with pegylated liposomal doxorubicin (PLD), 5-fluorouracil (5FU) and folinic acid (FA). METHODS: Thirty-one patients with hystologically- confirmed, inoperable HCC, received combination chemotherapy with PLD 25 mg/mq on d 1, 5FU 1200 mg/mq in 48 h continuous infusion, and oral FA 30 mg on d 1 and 2 every 3 wk until disease progression or intolerable toxicity. RESULTS: The median age was 65 years (range 41-82) and 28 patients were hepatitis C virus seropositive (90%). The majority of patients were Child-Pugh Class B (55%). Two patients showed a partial response (PR), and 16 had stable disease (SD). With a median follow-up of 14 mo, the median time to progression of all evaluable patients was 4 mo (95% CI 1.7-7). Median overall survival was 9 mo (95% CI 3-24 mo). After 1 year, 9 of 18 PR/SD patients were alive. Chemotherapy was well tolerated. CONCLUSION: PLD/FU/FA combination seems capable of achieving durable stabilization of HCC. The manageable toxicity supports a role for combination with other anticancer agents.     

Activity and safety of pegylated liposomal doxorubicin,5-fluorouracil and folinic acid in inoperable hepatocellular carcinoma: A phase Ⅱ study

AIM: To improve the results of New therapeutic strategies in hepatocellular carcinoma (HCC). We have conducted a phase Ⅱ study with pegylated liposomal doxorubicin (PLD), 5-fluorouracil (5FU) and folinic acid (FA).METHODS: Thirty-one patients with hystologically-confirmed, inoperable HCC, received combination chemotherapy with PLD 25 mg/mq on d 1, 5FU 1200 mg/mq in 48 h continuous infusion, and oral FA 30 mg on d 1 and 2 every 3 wk until disease progression or intolerable toxicity.RESULTS: The median age was 65 years (range 41-82) and 28 patients were hepatitis C virus seropositive (90%).The majority of patients were Child-Pugh Class B (55%).Two patients showed a partial response (PR), and 16 had stable disease (SD). With a median follow-up of 14 mo, the median time to progression of all evaluable patients was 4 mo (95% CI 1.7-7). Median overall survival was 9 mo (95% CI 3-24 mo). After 1 year, 9 of 18 PR/SD patients were alive. Chemotherapy was well tolerated.CONCLUSION: PLD/FU/FA combination seems capable of achieving durable stabilization of HCC. The manageable toxicity supports a role for combination with other anticancer agents.     

S-1 plus gemcitabine chemotherapy followed by concurrent radiotherapy and maintenance therapy with S-1 for unresectable pancreatic cancer

AIM: To investigate the feasibility and efficacy of the combination of S-1 with gemcitabine followed by oral S-1 with concurrent radiotherapy (intensity modulated radiotherapy, IMRT) and maintenance therapy with S-1 for locally advanced pancreatic cancer.METHODS: Subjects selected in the study were patients who had unresectable and locally advanced pancreatic cancer without distant metastases, adequate organ and marrow functions, an Eastern Cooperative Oncology Group performance status of 0-1 and no prior anticancer therapy. Initially the subjects received two cycles of chemotherapy, oral administration of S-1 40 mg/m² twice daily from day 1 to day 14 of a 21-d cycle, with 30-min intravenous infusions of gemcitabine 1000 mg/m² on day 1 and day 8. Two weeks after the completion of chemotherapy, S-1 was administered orally with concurrent IMRT. Oral S-1 was administered at a dose of 80 mg/m² per day twice daily from day 1 to day 14 and from day 22 to day 35. Radiation was concurrently delivered at a dose of 50.4 Gy (1.8 Gy/d, 5 times per week, 28 fractions). One month after the completion of chemotherapy and radiotherapy, S-1 was administered orally at a dose of 80 mg/m² per day twice daily for 14 d, followed by a 14-d rest period. This cycle was repeated as maintenance therapy, until unacceptable toxicity occurred or the disease worsened. Thirty-two patients were involved in this study. The median follow-up was 15.6 mo (range: 8.6-32.3 mo).RESULTS: Thirty-two patients completed the scheduled course of chemotherapy, while 30 patients (93.8%) received chemoradiotherapy with two patients ceasing to continue with radiotherapy. The major toxic effects were nausea and leukopenia. There was no grade 4 toxicity or treatment-related death. According to the Response Evaluation Criteria in Solid Tumors criteria, the objective tumor response was partial response in 17 (53.1%) patients, stable disease in 9 (28.1%), and progressive disease in 6 (18.8%). The median overall survival and median progression-free survival were 15.2 mo and 9.3 mo, respectively. The survival rates at 1 year and 2 years were 75% and 34.4%, respectively.CONCLUSION: The combination of S-1 with gemcitabine followed by oral S-1 with IMRT and maintenance therapy with S-1 alone in patients with locally advanced pancreatic cancer may be considered a well-tolerated, promising treatment regimen.     

Systemic gemcitabine combined with intra-arterial low-dose cisplatin and 5-fluorouracil for advanced hepatocellular carcinoma： Seven cases

The combination of intra-arterial low-dose cisplatin and 5-fluorouracil （5-FU） is effective against advanced hepatocellular carcinoma （HCC）. Systemic gemcitabine chemotherapy seems effective in many cancers. We report the results of combination therapy with systemic gemcitabine, intra-arterial low-dose cisplatin and 5-FU （GEMFP）. Seven patients with non-resectable advanced HCC were treated with GEMFP. One course of chemotherapy consisted of daily intra-arterial cisplatin （20 mg/body weight/hour on d 1, 10 mg/body weight per 0.5 h on d 2-5 and 8-12）, followed by 5-FU （250 mg/body weight per 5 h on d 1-5 and 8-12） via an injection port. Gemcitabine at 1000 mg/m2 was administered intravenously at 0.5 h on d 1 and 8. The objective response was 57%. The response to GEMFP was as follows： complete response （no patients）, partial response （four patients）, stable disease （three patients）, and progressive disease （no patients）. The median survival period was 8 mo （range, 5-55）. With regard to the National Cancer Institute Common Toxicity Criteria （NCI-CTC） grade 3 or 4 adverse reactions, seven （100%）, seven, six （86%） and one （14%） patients developed leukopenia, neutropenia, thrombocytopenia and anemia, respectively. GEMFP may potentially be effective for non- resectable advanced HCC, but it has severe hematologic toxicity.     

Doxetaxel in previously treated non-small cell lung cancer patients: clinical efficacy and quality of life

Docetaxel (Taxotere) is one of the most active new generation chemotherapy agents against advanced non-small cell lung cancer (NSCLC). This study aimed to determine the activity, toxicity and impact on the quality of life (QOL) in patients treated with docetaxel after failure with first-line platinum-based combination chemotherapy. Twenty-one patients with advanced NSCLC who had previously received the platinum-containing regimen were treated with docetaxel 75 mg/m2 every 3 weeks. QOL was assessed at intervals during the treatment period using the Functional Assessment of Cancer Treatment - Lung (FACT-L). Of the 21 patients enrolled, 16 were able to be evaluated for response and 20 were included in the toxicity analysis. The median age was 57 (range, 39-75 years). A median of 3 cycles was given (range, 1-9). Of the 16 evaluatable patients, there was one partial response (6.3%) and 4 with stable disease (25%). The median survival time was 8.1 months and the 1-year survival rate was 25%. Myelosuppression and peripheral neuropathy were the major toxicities. Grade 3/4 neutropenia and paresthesia occurred in 6 patients (30%) and 3 patients (15%), respectively. There was no significant improvement or deterioration in the overall FACT-L, TOI (Trial Outcome Index) and lung cancer symptom scores during the treatment. Symptom improvement was noted, in particular for shortness of breath and weight loss in the majority of patients. It is concluded that docetaxel is a well tolerated second-line treatment for recurrent NSCLC. Of particular importance was that the treatment did not negatively impact the overall quality of life, on the contrary, did palliate some of the lung cancer related dash symptoms in many patients.     

Gallbladder cancer in India: a dismal picture

BACKGROUND: Gallbladder cancer (GBC) is one of the most common gastrointestinal malignancies. The data regarding GBC are, however, limited. METHODS: Records of 634 patients with GBC over a 10-year period were examined with regard to the clinical presentation, investigative findings, treatment, operative findings and outcome. RESULTS: The mean age of patients was 51 +/- 11 years and men : women ratio was 0.36:1.00. Pain, jaundice and hepatomegaly were seen in 81.0%, 76.0% and 61.5% patients, respectively. On imaging, a mass replacing the gallbladder was seen in 73% patients. Gallstones were present in 54% patients. Surgery was carried out in 291 (46%) patients and endoscopic treatment in 72 (19%) patients but no intervention was carried out in the remaining patients because of disseminated disease. Among the patients who were operated on, 2.0% had stage I GBC, 3.4% stage II, 17.5% stage III, 47.0% stage IVa and 29.8% stage IVb. Radical resection was possible in 133 (46%) patients. The 30-day mortality was 10% with most (90%) deaths in patients with stage IV disease. The median survival after simple cholecystectomy and radical surgery was 33.5 and 12.0 months, respectively. However, among those who underwent debulking, palliative bypass or exploratory laparotomy alone, the survival ranged between 1 and 3 months. Logistic regression analysis showed that only radical resection improved the long-term survival (P < 0.05). CONCLUSIONS: The majority of patients with GBC in India have advanced unresectable disease. Detection of GBC at an early stage is incidental and rare but is associated with long-term survival. Radical surgery, when feasible, is the only option for achieving long-term survival.     

Combination chemotherapy of advanced non-Hodgkin lymphoma with bleomycin, adriamycin, cyclophosphamide, vincristine, and prednisone (BACOP).

Seventy-three patients with advanced non-Hodgkin lymphoma were treated with bleomycin, Adriamycin, cyclophosphamide, vincristine (Oncovin) and prednisone (BACOP), administered intensively during a 7-wk induction course followed by intermittent cycles every 3 wk for a total of 28 wk. The objective response in 44 evaluable nonleukemic patients with diffuse histology was 86%, with 66% achieving a complete remission (CR), varying from 80% for diffuse poorly differentiated lymphocytic (DPDL) to 56% for diffuse histiocytic (DH) lymphoma. In patients with nodular histology 89% (8/9) achieved a CR with a projected 75% of patiients in CR at 14 mo. Median follow-up from time of CR for nodular histology was 17 mo. The projected median duration of CR in diffuse histology was 14 mo. with median survival 14 mo. Patients with a partial response survived a median of 7 mo, compared to 3 mo for nonresponders. Of 29 patients with diffuse histology, 17 (59%) have remained disease free for 5-34 mo with a median follow-up of 12 mo. Survival beyond 20 mo has been projected for 42% of patients with diffuse histology (58% with DPDL and 32% with DH). The central nervous system (CNS) was involved in a total of 11/44 (25%) patients with diffuse histology, including 5 with primary CNS relapse. BACOP resulted in a higher CR rate and longer survival than a previous three-drug program (COP), especially in patients with diffuse histology.     

Combination chemotherapy with carboplatin and docetaxel for elderly patients with non-small-cell lung cancer

The efficacy and toxicity of treatment with carboplatin (AUC= 5)+ docetaxel (70mg/m2) were analyzed retrospectively in 27 elderly patients with advanced non-small-cell lung cancer (NSCLC) aged 70 years or more. The median age of the patients was 74 years (range, 70-83 years). The performance status (ECOG), clinical stage, and tumor histology in the patients were as follows: PS: PS 0, 12 patients; PS 1, 11 patients; PS 2, 4 patients; disease stage: stage IIIA, 5 patients; stage IIIB, 11 patients; stage IV, 11 patients; tumor histology: adenocarcinoma, 18 patients; squamous cell carcinoma, 9 patients. The median number of treatment cycles administered was 4. The median survival time was 11.1 months and the 1-year survival rate was 40.7%. The response rate was 33.3%. The major toxicities were leukopenia and neutropenia; grade 3/4 neutropenia occurred in 22 patients (81.5%). Nonhematologic toxicities were generally mild, including grade 3 anorexia in 13 patients (48.1%) and grade 3 febrile neutropenia in 9 patients (33.3%). No treatment-related deaths were observed. Thus, it was concluded that the combination of carboplatin + docetaxel is a feasible, well-tolerated, and effective regimen for fit elderly patients with NSCLC. Prospective studies comparing carboplatin + docetaxel with third-generation single-agent chemotherapy or non-platinum-based combination chemotherapy are needed to confirm the efficacy and safety of this drug combination.