Rohini Hawaldar

Elective versus Therapeutic Neck Dissection in Node-Negative Oral Cancer

BACKGROUND Whether patients with early-stage oral cancers should be treated with elective neck dissection at the time of the primary surgery or with therapeutic neck dissection after nodal relapse has been a matter of debate. METHODS In this prospective, randomized, controlled trial, we evaluated the effect on survival of elective node dissection (ipsilateral neck dissection at the time of the primary surgery) versus therapeutic node dissection (watchful waiting followed by neck dissection for nodal relapse) in patients with lateralized stage T1 or T2 oral squamous-cell carcinomas. Primary and secondary end points were overall survival and disease-free survival, respectively. RESULTS Between 2004 and 2014, a total of 596 patients were enrolled. As prespecified by the data and safety monitoring committee, this report summarizes results for the first 500 patients (245 in the elective-surgery group and 255 in the therapeutic-surgery group), with a median follow-up of 39 months. There were 81 recurrences and 50 deaths in the elective-surgery group and 146 recurrences and 79 deaths in the therapeutic-surgery group. At 3 years, elective node dissection resulted in an improved rate of overall survival (80.0%; 95% confidence interval [CI], 74.1 to 85.8), as compared with therapeutic dissection (67.5%; 95% CI, 61.0 to 73.9), for a hazard ratio for death of 0.64 in the elective-surgery group (95% CI, 0.45 to 0.92; P=0.01 by the log-rank test). At that time, patients in the elective-surgery group also had a higher rate of disease-free survival than those in the therapeutic-surgery group (69.5% vs. 45.9%, P<0.001). Elective node dissection was superior in most subgroups without significant interactions. Rates of adverse events were 6.6% and 3.6% in the elective-surgery group and the therapeutic-surgery group, respectively. CONCLUSIONS Among patients with early-stage oral squamous-cell cancer, elective neck dissection resulted in higher rates of overall and disease-free survival than did therapeutic neck dissection. (Funded by the Tata Memorial Centre; ClinicalTrials.gov number, NCT00193765.).

Single-Injection Depot Progesterone Before Surgery and Survival in Women With Operable Breast Cancer: A Randomized Controlled Trial

PURPOSE Many nonrandomized studies have suggested better outcome for patients with breast cancer who undergo surgery during the luteal (progestogenic) phase of their menstrual cycle, but this is controversial. We investigated the effect of a single preoperative injection of hydroxyprogesterone in women with operable breast cancer (OBC) in a randomized controlled trial (ClinicalTrials.gov identifier, NCT00123669). PATIENTS AND METHODS One thousand patients with OBC were randomly assigned to receive surgery or an intramuscular injection of depot hydroxyprogesterone 500 mg 5 to 14 days before surgery. Primary and secondary end points were disease-free survival (DFS) and overall survival (OS), respectively. An analysis by axillary lymph node status was preplanned. RESULTS At a median follow-up of 65 months among 976 eligible patients, 273 recurrences and 202 deaths were recorded. In the progesterone group versus control group, 5-year DFS and OS rates were 73.9% v 70.2% (hazard ratio [HR], 0.87; 95% CI, 0.68 to 1.09; P = .23) and 80.2% v 78.4% (HR, 0.92; 95% CI, 0.69 to 1.21; P = .53), respectively. In 471 node-positive patients, the 5-year DFS and OS rates in the progesterone group versus control group were 65.3% v 54.7% (HR, 0.72; 95% CI, 0.54 to 0.97; P = .02) and 75.7% v 66.8% (HR, 0.70; 95% CI, 0.49 to 0.99; P = .04), respectively. In multivariate analysis, DFS was significantly improved with progesterone in node-positive patients (adjusted HR, 0.71; 95% CI, 0.53 to 0.95; P = .02), whereas there was no significant effect in node-negative patients (P for interaction = .04). CONCLUSION A single injection of hydroxyprogesterone before surgery did not improve outcomes in all women with OBC. This intervention showed significant improvement in node-positive women that may be considered hypothesis generating. If replicated in other studies, this could be a simple and inexpensive intervention, especially in developing countries where the incidence of lymph node metastasis is high.

Does PET–CT scan have a role prior to radical re-resection for incidental gallbladder cancer?

BACKGROUND Radical re-resection is offered to patients with non-metastatic, invasive, incidental gallbladder cancer. Data evaluating (18)F-fluorodeoxyglucose positron emission tomography-computed tomography ((18)F-FDG PET-CT) in patients with incidental gallbladder cancer is sparse. AIM To evaluate the efficacy of integrated (18)F-FDG PET-CT in determining occult metastatic or residual local-regional disease in patients with incidental gallbladder cancer. METHODS Patients referred with incidental gallbladder cancer for radical re-resection were evaluated using multidetector computed tomography (MDCT) and PET-CT. Based on preoperative imaging, 24 out of 92 patients were found suitable for surgery. The two imaging modalities were evaluated with respect to residual and resectable disease. RESULTS In determining residual disease, MDCT had a sensitivity and positive predictive value (PPV) of 42.8%, each, while PET-CT had a sensitivity and PPV of 28.5 and 20%, respectively. In determining resectability, MDCT had a sensitivity, PPV, and accuracy of 100, 87.5, and 87.5%, respectively, as compared to PET-CT (sensitivity=100%, PPV=91.3%, accuracy=91.6%). CONCLUSIONS From our study, it appears that in patients with incidental gall bladder cancer without metastatic disease, PET-CT and MDCT seem to have roles complementing each other. PET-CT was able to detect occult metastatic or residual local-regional disease in some of these patients, and seems to be useful in the preoperative diagnostic algorithm of patients whose MDCT is normal or indicates locally advanced disease.

Quality of life after accelerated partial breast irradiation in early breast cancer: matched pair analysis with protracted whole breast radiotherapy.

AIMS To compare the quality of life of women with early breast cancer treated with either accelerated partial breast irradiation (APBI) or whole breast radiotherapy (WBRT). MATERIALS AND METHODS After matching for the American Brachytherapy Society criteria, the general European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and the breast cancer-specific BR23 modules were given to 48 women (23 APBI and 25 WBRT) who attended the radiotherapy clinic between May 2006 and December 2006 at Tata Memorial Hospital. RESULTS The median follow-up of patients in both groups was 3 years. The reliability and validity of the English and translated versions of the questionnaires were tested by Cronbach alpha (0.67-0.96) and Pearsons correlation for scale-scale correlation statistic (0.013-0.505). The scores for social functioning and financial difficulties in QLQ-C30 showed a trend towards a better outcome in the APBI group (P=0.025 and 0.019, respectively) and body image in BR23 was significantly better in the APBI group as compared with the WBRT group (P=0.005). When the analysis was restricted to women receiving chemotherapy in order to eliminate the confounding effect of the heterogeneous use of chemotherapy in the WBRT group, the difference in social functioning was not significant. However, financial difficulties and body image showed a trend towards a worse outcome in the WBRT group. CONCLUSION Favourable long-term results of APBI in terms of superior body image perception and lesser financial difficulties compared with WBRT need to be confirmed in larger prospective studies investigating the effect of APBI on quality of life and health economics in different ethnic groups and health care set-ups.

INFLUENCE OF SURGICAL TECHNIQUE ON AXILLARY SEROMA FORMATION: A RANDOMIZED STUDY

The aim of this study was to evaluate the influence of surgical technique in the form of electrocautery and suction drains on seroma formation following surgery for breast cancer. A prospective randomized study was carried out. One hundred and sixty patients with breast cancer who underwent surgery were allocated to four arms using a 2 × 2 factorial design. This method enabled us to evaluate the independent effect of two different causative factors on the incidence of postoperative seroma formation using a single dataset with limited numbers. The main outcome measure was postoperative seroma formation defined as a postoperative axillary collection requiring more than one aspiration after removal of the drain. The incidence of seroma in our institution is 90%. Incidence of postoperative seroma was 88.3% if electrocautery was used, which reduced to 82.2% if surgery was carried out using scissors for dissection and ligatures for haemostasis (P = 0.358). There was no influence on the incidence of seroma formation whether suction drain (84.6%) or corrugated drains (86.1%) were used (P = 0.822). The use of electrocautery in axillary dissection does not adversely affect postoperative seroma formation after surgery for breast cancer. The use of different drainage techniques has no bearing on the postoperative seroma formation. The surgical technique has no influence on the rate of seroma formation after surgery for breast cancer.

D2 Lymphadenectomy for Gastric Cancer in Tata Memorial Hospital: Indian Data Can Now Be Incorporated in Future International Trials

Background: While mortality rates after radical gastrectomy have decreased, there is considerable morbidity after D2 lymphadenectomy. In this study, we assessed the perioperative results of D2 gastrectomy for gastric cancer. Materials: Data of 159 patients who underwent D2 gastrectomy for gastric adenocarcinoma at Tata Memorial Hospital was analyzed for interim analysis. The extent of resection, blood loss, transfusions, duration of hospitalization, number of lymph nodes dissected, complications, morbidity and mortality were analyzed. Results: 130 and 29 patients underwent distal and total gastrectomy, respectively (2002–2005) by single specialized surgical unit. Median age was 55 years (range 21–78) and blood loss was 450 ml (range 100–2,200 ml). The median duration of hospitalization was 13 days (range 7–52 days). The median number of dissected lymph nodes was 15 (range 2–46). Minor and major morbidity rate was 4.4 and 4.4% respectively. Mortality rate was 1.25%. Conclusion: Morbidity and mortality following D2 lymphadenectomy is low in this first prospective study from India. With Japan and Western countries having polarized views on D2 lymphadenectomy, future international multicenter trials could also incorporate data such as ours from areas of high incidence of gastric cancer since perioperative outcomes would no longer cloud their results and might provide a better global perspective on D2 lymphadenectomy.

Neoadjuvant Chemotherapy Followed by Radical Surgery Versus Concomitant Chemotherapy and Radiotherapy in Patients With Stage IB2, IIA, or IIB Squamous Cervical Cancer: A Randomized Controlled Trial

Purpose We compared the efficacy and toxicity of neoadjuvant chemotherapy followed by radical surgery versus standard cisplatin-based chemoradiation in patients with locally advanced squamous cervical cancer. Patients and Methods This was a single-center, phase III, randomized controlled trial ( ClinicalTrials.gov identifier: NCT00193739). Eligible patients were between 18 and 65 years old and had stage IB2, IIA, or IIB squamous cervical cancer. They were randomly assigned, after stratification by stage, to receive either three cycles of neoadjuvant chemotherapy using paclitaxel and carboplatin once every 3 weeks followed by radical hysterectomy or standard radiotherapy with concomitant cisplatin once every week for 5 weeks. Patients in the neoadjuvant group received postoperative adjuvant radiation or concomitant chemotherapy and radiotherapy, if indicated. The primary end point was disease-free survival (DFS), defined as survival without relapse or death related to cancer, and secondary end points included overall survival and toxicity. Results Between September 2003 and February 2015, 635 patients were randomly assigned, of whom 633 (316 patients in the neoadjuvant chemotherapy plus surgery group and 317 patients in the concomitant chemoradiation group) were included in the final analysis, with a median follow-up time of 58.5 months. The 5-year DFS in the neoadjuvant chemotherapy plus surgery group was 69.3% compared with 76.7% in the concomitant chemoradiation group (hazard ratio, 1.38; 95% CI, 1.02 to 1.87; P = .038), whereas the corresponding 5-year OS rates were 75.4% and 74.7%, respectively (hazard ratio, 1.025; 95% CI, 0.752 to 1.398; P = .87). The delayed toxicities at 24 months or later after treatment completion in the neoadjuvant chemotherapy plus surgery group versus the concomitant chemoradiation group were rectal (2.2% v 3.5%, respectively), bladder (1.6% v 3.5%, respectively), and vaginal (12.0% v 25.6%, respectively). Conclusion Cisplatin-based concomitant chemoradiation resulted in superior DFS compared with neoadjuvant chemotherapy followed by radical surgery in locally advanced cervical cancer.

Feasibility of laparoscopic abdomino-perineal resection for large-sized anorectal cancers: a single-institution experience of 59 cases.

BACKGROUND Laparoscopic surgery for anorectal carcinoma is steadily gaining acceptance. While feasibility has already been reported, there are no reports addressing the impact of the actual size of large tumors on laparoscopic resectability. AIM To assess the feasibility and short-term results (including oncological surrogate end points) of performing laparoscopic abdomino-perineal resection (APR) for large rectal cancers. MATERIALS AND METHODS Data of 59 patients undergoing laparoscopic APR (LAPR) for anorectal malignancies were reviewed retrospectively. Outcomes were evaluated considering the surgical procedure, surface area of the tumor and short-term outcomes. RESULTS Of the 59 cases, LAPR could be completed in 53 (89.8%) patients. Thirty-one (58.4%) patients had Astler-Coller C2 stage disease. The mean surface area of the tumors was 24+/-17.5 (4-83) cm2. The number of median lymph nodes harvested per case was 12 (1-48). Circumferential resection margin (CRM) was positive in 11 (20.7%) patients. No mortality was reported. CONCLUSION This appears to be the first report analyzing the impact of the size of the rectal tumor in LAPR. The data clearly indicates that LAPR is not hampered by the size of the tumor. There appears to be a need for preoperative radiotherapy and chemotherapy before undertaking surgery on larger tumors in view of the higher circumferential resection margin positivity.

The Vascular Stapler in Uncinate Process Division during Pancreaticoduodenectomy: Technical Considerations and Results

Background: Few studies describing the use of stapling devices for uncinate process division during pancreaticoduodenectomy (PD) have data regarding outcomes. Our aim is to discuss our technique and the peri-operative outcomes with the use of the linear vascular stapler for division of the uncinate process during PD. Materials and Methods: 19 consecutive patients who underwent stapler division of the uncinate process (‘stapler’ group) were compared to 20 consecutive patients operated without stapler (‘no-stapler’ group). Results: The overall surgical morbidity in the no-stapler group was 25% (5/20) and 31.6% (6/19) in the stapler group (p = 0.731). The mean blood loss in the no-stapler group was 1,077.5 ± 594 ml compared to 778 ± 302 ml in the stapler group (p = 0.113). The mean operative duration was 498 ± 105 min in the no-stapler group and 490 ± 60 min in the stapler group (p = 0.773). The average number of lymph nodes retrieved was 6.1 ± 3 in the no-stapler group versus 5.9 ± 4 in the stapler group (p = 0.627). Neither group had positive resection margins. Conclusion: Stapler division of the uncinate process for selected periampullary tumours compares well with the conventional method, has comparable peri-operative outcomes without compromising oncological radicality and has the potential to simplify uncinate resection.

HER 2 status in invasive breast cancer: immunohistochemistry, fluorescence in-situ hybridization and chromogenic in-situ hybridization.

INTRODUCTION HER2/neu gene status in breast cancers can be evaluated by targeting protein and gene - immunohistochemistry (IHC) and fluorescence in-situ hybridization (FISH). Recent studies have shown chromogenic in-situ hybridization (CISH) as a relatively cheaper alternative. MATERIALS AND METHODS Forty-three nonconsecutive, randomly selected primary invasive breast cancer cases were evaluated for c-erbB-2 (HER2 protein) by IHC and gene amplification by FISH and CISH. Results of each of the same were compared. RESULTS CISH showed approximately 90% and 100% concordance for IHC negative and positive cases, respectively; while approximately 94.4% and 91% concordance with FISH amplified and non-amplified cases, respectively. CONCLUSION This study showed feasibility of incorporation of CISH as a low cost option in routine management of breast carcinoma in the Indian setting. Secondly, reconfirmation of IHC negative and positive cases can be done by CISH.