Volume 4 Issue 1
Research Article: Efficacy and Safety of Erlotinib Addition to Concurrent Chemoradiation in Patients of Unresectable Esophageal Carcinoma: a Comparative Study.
Shyamji Rawat and Hemu Tandan*
Background: Erlotinib is an oral EGFR Tyrosine Kinase (TK) inhibitor. Clinical trials of Erlotinib in combination with concurrent chemoradiotherapy in unresectable esophageal carcinoma have demonstrated improved clinical outcomes.
Purpose of study: We have prospectively evaluated the efficacy and safety of Erlotinib with Concurrent Chemoradiotherapy (CRT) in unresectable esophageal carcinoma compared with standard CRT.
Methods: In this prospective, two arm, comparative study, total 50 unresectable esophageal carcinoma patients received either Erlotinib (150 mg/day) with CRT or standard CRT. Treatment of CRT included cisplatin 50 mg/m2 intravenously weekly concurrently with external beam radiation therapy. Tumor response was assessed as per RECIST v 1.1 criteria. Toxicity and Adverse Events (AEs) were assessed as per CTCAE v 4.
Results: The higher number of patients achieved complete response in the Erlotinib plus CRT group than the CRT group [14/25, 56% vs. 10/25, 40%, p = 0.248], but it was statistically not significant. The adverse events commonly encountered in both the treatment groups were majority of grade 1/2/3. A higher incidence of skin reaction hypocalcaemia and GI toxicity was noted in the Erlotinib plus CRT group in comparison to CRT. No grade IV and V toxicity were observed in Erlotinib with CRT. Erlotinib was observed to be safe with few manageable toxicity profiles.
Conclusion: The addition of Erlotinib to cisplatin based concurrent chemoradiotherapy resulted in mild improvement in the tumor response and was found to be feasible and safe in unresectable esophageal carcinoma.
Keywords: Erlotinib; Esophageal; Gastro-esophageal junction; Carcinoma; EGFR; Tyrosine kinase inhibitor
Cite this Article: Rawat S, Tandan H. Efficacy and Safety of Erlotinib Addition to Concurrent Chemoradiation in Patients of Unresectable Esophageal Carcinoma: a Comparative Study. Int J Hepatol Gastroenterol. 2018; 4(1): 024-028.
Published: 19 February 2018
Research Article: Long-Term Follow-Up of Hepatitis B e Antigen-Negative Hepatitis B Virus Carriers according to the Status of HBV DNA and ALT Levels
Fumio Imazeki*, Makoto Arai, Tatsuo Kanda, Rintaro Mikata, Shingo Nakamoto and Osamu Yokosuka
Background and Aims: We examined the long-term prognosis of hepatitis B e antigen (HBeAg)-negative carriers according to the status of HBV DNA and ALT levels.
Methods: A total of 198 HBeAg-negative carriers visiting Chiba University Hospital between 2002 and 2005 were followed retrospectively for a median duration of 7.6 years. They were divided into 4 groups according to their maximal levels of HBV DNA and ALT, and were evaluated three times or more during the first year of follow-up: group A: 68 patients with HBV DNA <4 log copies (LC)/ml and ALT =30IU/l, group B: 31 with HBV DNA <4LC/ml and ALT >30IU/l, group C: 35 with HBV DNA =4LC/ml and ALT =30IU/l, group D: 64 with HBV DNA =4LC/ml and ALT >30IU/l.
Results: Hepatocellular Carcinoma (HCC) developed in 1, 0, 2 and 6 patients in groups A, B, C and D, respectively. These 9 patients were all cirrhotic except for 1 each in groups C and D. A significant factor associated with HCC development was cirrhosis, hepatitis flare-up, HBcrAg, AST, G-GTP, AFP, HBV DNA levels and platelet counts. Two patients died during follow-up, 1 of gastrointestinal bleeding and the other of HCC. Among 68 patients in group A, none developed hepatitis flare-up defined as ALT >80 IU/L and HBV DNA =4LC/ml.
Conclusions: HBeAg-negative carriers with HBV DNA<4 LC/ml and ALT=30 during the first year of follow-up showed favorable prognosis if inactive cirrhosis could be excluded.
Cite this Article: Imazeki F, Arai M, Kanda T, Mikata R, Nakamoto S, et al. Long-Term Follow-Up of Hepatitis B e Antigen-Negative Hepatitis B Virus Carriers according to the Status of HBV DNA and ALT Levels. Int J Hepatol Gastroenterol. 2018; 4(1): 017-023.
Published: 15 February 2018
Ahmed M. Abdel Modaber1*, Ahmed Hammad1 and Vusal Aliyev2
This prospective randomized study included 36 patients who presented to the Emergency department with perforated peptic ulcers. All these patients presented within 24 hours from the start of symptoms, with no shock and no major medical co-morbidities. The odd number patient entered the laparoscopic group while patients with even number entered open group. Technique used for repair in both groups was a modification of Grahams maneuver. The mean operative time in the laparoscopic group was (150.1 ± 13.2 minutes), while in the open one, it was (106.3 ± 12.1 minutes). Two patients of the laparoscopic group were converted to open and were excluded from the study with a conversion rate 10%. The reasons were very large perforation in one patient and difficulty in placing the sutures through the friable edges of the perforation in the second patient. The site of perforation was mainly in the duodenum (83%) in the laparoscopic group and (77%) in the open group. The size of perforation was less than 10mm in both groups. The mean post-operative pain score in the open group (5.3), while in the laparoscopic one was (1.3). Bowel habit returns earlier in the laparoscopic group than the open one. Start of oral diet intake was significantly early in the laparoscopic group than the open one (3.7 days). Naso-gastric tube removal was significantly earlier in the laparoscopic group than the open one. Hospital stay was significantly longer in the open group than the laparoscopic one. Deep venous thrombosis occurred more in open group than in laparoscopic group. The wound complications were more common in the open group, six cases. Pulmonary infections was higher after open surgery than laparoscopic surgery. There are two cases of Suture leakage that were diagnosed by gastrographin meal, One patient in the open group developed suture leakage which was managed by surgery, also one patient developed suture leakage was reported in the laparoscopic group which was managed conservatively. Post-operative intra-abdominal collection occurred only in one patient of the laparoscopic group. The patient was diagnosed by ultra-sonography and C.T. The patient was managed conservatively by U/S guided aspiration and improved. Two patients from the open group presented with incisional hernia on follow up in the outpatient clinic, while patients belonging to the laparoscopic group did not. Also, we found that there were recurrence of peptic ulcer disease in two patients in laparoscopic group and three patients in the open group. We found that the laparoscopic repair of perforated peptic ulcers is superior to the open repair in regard to postoperative pain, return of bowel habit, start of oral diet and length of hospitalization. Currently, the main drawbacks of laparoscopic repair are a longer operation and a higher incidence of intra-abdominal collection. The open repair has a higher rate of pulmonary infections, wound infection. Suture leakage was reported in one case in the open group and in one case in laparoscopic group.
Cite this Article: Abdel Modaber AM, Hammad A, Aliyev V. Laparoscopic versus Open Simple Closure for Perforated Peptic Ulcer. Int J Hepatol Gastroenterol. 2018; 4(1): 001-009.
Published: 10 January 2018
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