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Aims: There is no consensus for palliative chemotherapy regimen in metastatic gallbladder cancer. We did a retrospective study to compare the treatment outcome in patients of metastatic gallbladder cancer treated with either gemcitabine + cisplatin (regimen A) or oral capecitabine (regimen B) alone., Subjects and Methods: A total of 67 patients between January 2015 and September 15 treated with either regimen A or regimen B were retrospectively evaluated. Statistical analysis was done in June 2019. Kaplan-Meir and Log rank test were used to compare survival between two arms., Results: Out of 67 patients, 31/67 (46%) received regimen A, and 36/67 (54%) received regimen B. Male to female ratio was 1:3. About 42% patients in regimen A and 20% in regimen B required palliative stenting. Median number of chemotherapy cycles was 4 in both regimen A (range 1->6) and regimen B (range 1->6). Patients receiving 3 cycles and 6 cycles of chemotherapy in regimen A and regimen B was 68% and 31% versus 70% and 63%, respectively (P = 0.86). Response assessment as any response (complete response + partial response + disease was stable) after 3 cycles and 6 cycles was 71% and 57% (P = 0.20), 44% and 39% (P = 0.29), in regimen A and B, respectively. Median survival was 23 weeks (range 2-106 weeks) in regimen A and 15 weeks (range 4-83 weeks) in regimen B (P = 0.40)., Conclusions: The present study shows gemcitabine and cisplatin has nonsignificant better survival compared to oral capecitabine. However, oral capecitabine is more convenient and easy to administer. Studies with larger sample size are needed to further establish the standard chemotherapy guidelines., Competing Interests: None

Aim: Chemo-radiotherapy (CRT) is the standard of care for treating almost all cervical carcinoma patients on the basis of the National Cancer Institute (NCI) alert. The disease burden in developing countries is more advanced with poor general condition than in patients in the trials prompting the NCI alert. Therefore, practicing CRT as standard of care should be tested in these patients., Methods: A randomized controlled trial was conducted comparing radiotherapy (RT) alone with CRT (cisplatin 40 mg/m(2) weekly × 5) in patients with localized stage Ib to IVa cervical carcinoma between September 2006 and December 2008. External beam RT was delivered using a telecobalt unit. This was followed by 12-18 Gy of brachytherapy., Results: In total, 305 patients were recruited: RT alone (150) and CRT (155). The median follow up was 34 months. Locoregional relapse-free survival (LRFS) at 2 years was 55 and 54% for the RT and CRT group, respectively, with a median LRFS time of 27 and 30 months for the RT and CRT group, respectively, (P = 0.624). Overall survival (OS) at 2 years was 58 and 60%, with a median OS of 31 and 34 months for the RT and CRT group, respectively; (P = 0.9). The toxicity profile, both acute and late, were comparable in both groups;, Conclusion: No improvement in outcome was seen with addition of cisplatin. In the Indian subcontinent where patients present at late stages with poor general condition and limited access to good supportive care, RT alone still remains a valid option., (© 2013 Wiley Publishing Asia Pty Ltd.)

Background and Purpose: Following our phase II experience, a randomised trial was undertaken to evaluate the efficacy of adding chemotherapy to radiotherapy in patients with unresectable squamous cell cancer of the esophagus., Patients and Methods: Patients randomised to the RT group received 50 Gy/25 fx/5 weeks of teletherapy followed 1-2 weeks later with 12 Gy/2 fx of high-dose-rate intra-lumenal brachytherapy spaced a week apart. Following the first 3 years of recruitment, due to unexpected late morbidity, brachytherapy was excluded and the protocol modified to 66 Gy/33 fx/6.5 weeks. The CRT group received identical radiotherapy with concurrent weekly cisplatin at 35 mg/m(2) for 6-7 cycles., Results: Between April 1999 and December 2005, 125 patients were randomised to a RT (n=60) or CRT group (n=65). Radiotherapy treatment was completed in 78% (47/60) of the RT group and 89% (58/65) of the CRT group (P=0.10). Six or more cycles of cisplatin could be delivered in 63% (41/65), which resulted in RTOG grade 3 neutropenia of 3%. Late morbidity in the form of ulcers (5% vs. 15% odds ratio 0.29, 95% CI 0.08-1.11, P=0.08) and strictures (13% vs. 28%, odds ratio 0.40, 95% CI 0.16-1.01, P=0.05) was observed in the RT and CRT groups, respectively. At a median follow up of 23 months of all patients alive (range 6-82 months) and with 95/125 events, the median, 1, 2 and 5 year projected survival was 7.1 months, 32.3%, 22.8% and 13.7% vs. 13.4 months, 57.6%, 38.9% and 24.8% for the RT and CRT groups, respectively (hazard ratio 0.65, 95% CI 0.44-0.98, P=0.038)., Conclusions: The addition of concurrent cisplatin to radiotherapy resulted in a modest improvement in survival and was associated with manageable additional acute and late morbidity.

Background and Purpose: To determine the safety and efficacy of concomitant boost radiotherapy (CBRT) with concurrent cisplatin chemotherapy (CT) in advanced head and neck cancers., Patients and Methods: Between February 2000 and June 2001, 95 previously untreated patients of advanced head and neck cancers were treated with CBRT and concurrent cisplatin CT. CBRT consisted of: phase I--44 Gy/22fx/4.5 weeks, phase IIa--16 Gy/8fx/1.5 weeks and phase IIb--10 Gy/8fx (delivered as a second daily fraction after a gap of 6h along with phase IIa). CT (cisplatin 35 mg/m(2)) was administered weekly usually preceding CBRT by an hour., Results: The median follow-up was 39 months (range 8-50 months). CBRT compliance (70 Gy in 40-44 days) was seen in 66% (63/95). Six cycles of CT was delivered in 73% (69/95). Acute grade III/IV mucosal toxicity was seen in 79% and resulted, on average, in a total weight loss of 7.9 kg from a mean pretreatment weight of 51 kg. Nasogastric tube placements were required in 26% (25/95) for an average duration of 19.3 days. Grade III leucopenia was seen in 2%. Mortality during and within 30 days of treatment was seen in 14% (13/95). Crude incidence of late subcutaneous fibrosis (grade III) was 21% (12/57) and a case of mandibular necrosis and thyroid cartilage necrosis each were seen. Initial loco regional disease clearance was seen in 59% (56/95) and the Kaplan-Meier estimates of 3-year loco-regional control rate and overall survival were 25% (median 7 months, 95% C.I. 3-11) and 27% (median 12 months, 95% C.I. 8-16), respectively., Conclusions: On present evidence, in the settings of a developing country, CBRT with concurrent cisplatin cannot be recommended as primary therapy in advanced head and neck cancers without formal comparison with other treatment modalities.

Between August 1996 and May 1999, 50 consecutive, previously untreated patients with carcinoma of the esophagus and who were inoperable for various reasons were treated with weekly doses of cisplatin (35 mg/m2, maximum 7 cycles) concurrent with either 66 Gy/33 fractions external beam radiotherapy (EBRT) (n = 42) or 50 Gy/25 fractions EBRT and two insertions of high-dose-rate intraluminal radiotherapy of 6 Gy each, spaced a week apart (n = 8). Eighty-two percent (41/50) of the patients received the stipulated radiotherapy (RT) dose. Seventy-six percent (38/50) received at least 6 cycles of chemotherapy. Neutropenia in the form of WHO grade 11-12%, (6/50) and grade III-2% (1/50) was observed. Grade III emesis was seen in 8% (4/50). Improvement in the swallowing status was seen in 84% (42/50). Median duration of dysphagia relief was 6 months. The median overall survival was 9 months with 17% estimated to be alive after 4 years. Combined treatment with single agent cisplatin and definitive radiotherapy for inoperable cancer of the esophagus is safe, well tolerated and reasonably efficacious.

Background: Cisplatin (CDDP)-based concurrent chemoradiotherapy (CRT) is the standard of care in locally advanced head and neck cancers (HNCs). CDDP, a known nephrotoxic drug, has been administered in three different protocols. Baseline renal function needs to be known before CRT. Renal function can be measured directly by measuring the measured glomerular filtration rate (mGFR) using radioisotope and indirectly by either serum creatinine (SCR) levels or estimated GFR (eGFR) using mathematical formulae "abbreviated modification of diet in renal disease (aMDRD)" and "Cockcroft-Gault (CG)." The present study was performed to see the prevalence of pretreatment renal insufficiency (RI) in HNC patients and to find a realistic method using CG and aMDRD formulae for assessing RI instead of doing mGFR and to compare the nephrotoxicity in three CDDP protocols. Materials and Methods: The study was carried out between January 2005 and December 2006. Consecutive patients of HNC undergoing RT/CRT were included. Renal function using parameters SCR, mGFR, and eGFR using CG and aMDRD formulae was estimated for pre- and post-treatment and during follow-up. Results: Of 295 eligible patients, baseline prevalence of RI was in 17% by mGFR, 6% by SCR, 13% by aMDRD, and 41% patients by CG formula. aMDRD correlated better than CG with the mGFR. Of the 145 patients of CRT, pretreatment RI was seen in 9% by aMDRD and 30% by CG formula as compared to 12% by mGFR and post treatment RI was seen in 12% by aMDRD and 43% by CG formula. All the three CDDP protocols showed similar fall in GFR post treatment, and late renal injury at 6 months was seen in 2%, 4%, and 3%, respectively. Conclusions: RI exists in HNC patient. RI assessment by SCR is inadequate and should be done by eGFR estimation using aMDRD or CG formula if not able to do mGFR. Different CDDP protocols have similar nephrotoxicity. [ABSTRACT FROM AUTHOR]

Background: Changes in salivary flow rate were studied in head and neck (H and N) cancer patients who, after receiving moderately accelerated radiotherapy (RT) and concurrent chemotherapy (CT), were free of disease at 1 year. Materials and Methods: Between July 2003 and July 2005, saliva estimation was performed for 36 patients of locally advanced (AJCC stages III and IV) squamous cell carcinoma of the H and N. RT, moderately accelerated (70Gy/35 fx/6 weeks) along with concurrent weekly cisplatin at 35 mg/m² (capped at 50 mg) with standard hydration and anti-emetic cover, was planned using conventional planning on telecobalt or 6 MV photons. The saliva flow rate was estimated for 5 min at rest (unstimulated) and after using lemon drops (stimulated) for the next 5 min at baseline (pre-treatment), 3, 6 and 12 months following treatment. Results: The median follow-up of this study was 29 months. Compared with baseline, by 3 months, a significant reduction in unstimulated (0.35 ml/min and 0.10 ml/min) and stimulated (0.97 ml/min and 0.28 ml/min) salivary flow rate was observed, respectively. This continued to decrease further till 6 months (0.06 ml/min and 0.17 ml/min) and, by 12 months, a minimal and non-significant recovery was observed in both unstimulated (0.08 ml/min) and stimulated salivary flow rates (0.22 ml/min), respectively. Conclusions: Salivary flow rates fall to a fourth of the baseline value with the above CT + RT protocol, with minimal recovery at 12 months following completion of treatment. [ABSTRACT FROM AUTHOR]

Purpose: To ascertain factors that could influence the development of ulcers and strictures in the definitive management of squamous cell carcinoma (SCC) of esophagus treated with external beam radiotherapy (EBRT), high-dose-rate (HDR) intralumenal radiotherapy (ILRT) with or without concurrent weekly cisplatin (CDDP @ 35 mg/m2) chemotherapy (CT).Materials and Methods: Between 1990-2005, 244 patients with inoperable SCC of esophagus were identified from our database and grouped into one of the following: those receiving at least 60 Gy EBRT (Gp E, n=44); EBRT followed by HDR-ILRT (Gp E+I, n=98); at least 50 Gy EBRT with CT (Gp E+C, n=68); EBRT+HDR-ILRT + CT (Gp E+I+C, n=34). Ulcers (discovered on endoscopy) and strictures evident on a barium swallow (which needed dilatations) were scored as treatment induced, if the biopsy was negative. Factors likely to influence their outcome were analyzed.Results: The groups were matched for all patient and disease characteristics except pretreatment hemoglobin and Karnofsky performance score (KPS), which were lower in Gp E. The incidence of ulcers was 7%, 8%, 6% and 21% (P=0.08) while that of strictures was 14%, 9%, 21% and 41% (P=0.00) for the groups E, E+I, E+C and E+I+C respectively. On univariate analysis, patients with better KPS (P=0.03), treated with narrow applicators (6 mm vs. 10 mm, P=0.00), received CT (P=0.00) or assigned to Gp E+I+C (P =0.00) were more likely to develop strictures, with a trend for development of ulcers in Gp. E+I+C (P=0.08). Logistic regression retained only Gp E+I+C for development of ulcers (OR 10.36, 95% CI 1.2-89.1, P=0.03) and strictures (OR 4.2, 95% CI 1.4-12.6, P=0.00).Conclusion: Treatment intensification as in Gp E+I+C results in about a three-fold increase in treatment induced late morbidity which can adversely impact on swallowing function and therefore emphasizes the need for optimisation of HDR-ILRT when used in a CT+RT protocol. [ABSTRACT FROM AUTHOR]

Purpose: The study aimed to apply the atlas of complication incidence (ACI) method to patients receiving radical treatment for head and neck squamous cell carcinomas (HNSCC), to generate constraints based on dose-volume histograms (DVHs), and to identify clinical and dosimetric parameters that predict the risk of grade 3 oral mucositis (g3OM) and pharyngeal dysphagia (g3PD).Methods and Materials: Oral and pharyngeal mucosal DVHs were generated for 253 patients who received radiation (RT) or chemoradiation (CRT). They were used to produce ACI for g3OM and g3PD. Multivariate analysis (MVA) of the effect of dosimetry, clinical, and patient-related variables was performed using logistic regression and bootstrapping. Receiver operating curve (ROC) analysis was also performed, and the Youden index was used to find volume constraints that discriminated between volumes that predicted for toxicity.Results: We derived statistically significant dose-volume constraints for g3OM over the range v28 to v70. Only 3 statistically significant constraints were derived for g3PD v67, v68, and v69. On MVA, mean dose to the oral mucosa predicted for g3OM and concomitant chemotherapy and mean dose to the inferior constrictor (IC) predicted for g3PD.Conclusions: We have used the ACI method to evaluate incidences of g3OM and g3PD and ROC analysis to generate constraints to predict g3OM and g3PD derived from entire individual patient DVHs. On MVA, the strongest predictors were radiation dose (for g3OM) and concomitant chemotherapy (for g3PD). [ABSTRACT FROM AUTHOR]