[Show abstract][Hide abstract] ABSTRACT: 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).
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.
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).
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.
[Show abstract][Hide abstract] ABSTRACT: Targeted sentinel node biopsy has been extensively validated. It has been incorporated into standard guidelines for axillary prediction in women with clinically node-negative operable breast cancer. However, the high cost of the gamma probe and the need for radiocolloid have limited its widespread acceptance in developing countries. We aimed to validate low axillary sampling as a reliable alternative method to sentinel node biopsy in a developing country.
An anatomically guided low axillary sampling removes the lower level I axillary fat with lymph nodes and the method was validated by completing axillary clearance in all women.
Three hundred fifty-five women with clinically node-negative operable breast cancer underwent validation of low axillary sampling, with lymph nodes identified in all of them. The median number of nodes identified in low axillary sampling was 5 with overall node-positivity of 32.1% (114 of 355). Ten of these 114 patients were wrongly identified as node-negative by the sampled lymph nodes, i.e. a false-negative rate of 8.8%. Further exploratory analysis showed that 6-node low axillary sampling gave an excellent false-negative rate of 1.5% with 95% sensitivity, which was comparable with the highly targeted sentinel node biopsy technique.
With an overall false-negative rate of 8.8% with 5-node low axillary sampling, and even better false-negative rate of 1.5% with 6-node low axillary sampling, axillary sampling is a low-cost technology, which is a reliable alternative to sentinel node biopsy for axillary nodal prediction in clinically node-negative breast cancer.
The National medical journal of India 09/2009; 22(5):234-6. · 0.78 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: This study was carried out to observe the trend in hormone receptors over the last 8 years in a tertiary cancer center in India. A total of 11,780 tumors analyzed for hormone receptors over the last 7 years were compared with the results of hormone receptor expression in a prior published study on 798 cases of breast cancer from the same institute. The patient's ages ranged from 18 to 102 years, Sixty percent of the patients were in the age group of 31-50 years. Seventy percent of the tumors were grade III tumors. The percentage of hormone receptor expression in breast cancer in the last 8 years varied from 52 to 57%. The overall receptor expression in the last 8 years shifted within a 5% range, confirming that the hormone receptor expression in Indian patients with breast cancer is low. However, there was redistribution within the pattern of estrogen receptor (ER) and progesterone receptor (PR) expression among tumors showing hormone receptor expression. Breast cancers showing only PR expression reduced dramatically from 21% in the year 1999 to in the year 2006, with a parallel increase in breast cancers showing combined ER and PR positivity (from 25 to 41.8%) and only ER expression (from 7.4 to 10.6%). The hormone receptor expression in breast cancers in India is and continues to be low but the high incidence of only PR-positive tumors in our population reported earlier was misrepresented.
Indian Journal of Pathology and Microbiology 04/2009; 52(2):171-4. DOI:10.4103/0377-4929.48909 · 0.47 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: 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.
To assess the feasibility and short-term results (including oncological surrogate end points) of performing laparoscopic abdomino-perineal resection (APR) for large rectal cancers.
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.
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.
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.
Indian Journal of Medical Sciences 04/2009; 63(3):109-14. DOI:10.4103/0019-5359.49288 · 1.67 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: At Tata Memorial Hospital, as a dedicated breast service at a tertiary cancer center in India, incompletely performed breast surgeries are encountered very frequently; however, there is a lack of published data on incompletely performed breast surgeries, revision surgeries, and their outcomes. Between March 2000 and November 2003, the authors audited 850 breast cancer patients who presented at their institute who had undergone surgery outside the institution. On the basis of study criteria, these patients were evaluated for completeness of surgery. Patients in whom the surgical intervention was considered incomplete were evaluated for a completion revision surgery. Of 850 patients, 424 (50%) had undergone surgical intervention with therapeutic intent. Of these 424 patients, 191 (45%) had received incomplete surgical intervention. Completion revision surgery was performed for 153 patients. Complete data were available for 148 patients, of which 123 patients had residual lymph nodes in the axilla. The median number of lymph nodes dissected was 8, and 64 patients had metastatic lymph node(s) left behind. A high proportion of patients with breast cancer who presented at the institute had undergone incomplete surgery outside in nonspecialty centers. Almost half of those patients who underwent incomplete surgery had surgically excisable disease left behind. The possible detrimental impact of inadequate surgical intervention may be very large in India and in other low-resource settings.
Cancer 11/2008; 113(8 Suppl):2347-52. DOI:10.1002/cncr.23839 · 4.89 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: There is currently no preoperative staging/scoring system available for gallbladder cancer. Unfortunately, in gallbladder cancer, patients manifest advanced stages of the disease. There is need for a methodology that can aid accurate preoperative staging and the subsequent treatment algorithm. We thus sought to validate a new scoring system, the Tata Memorial Hospital Staging System (TMHSS), for gallbladder cancer.
TMHSS is based on the cumulative impact of specific features of computed tomographic scan, presence or absence of jaundice, and serum cancer antigen 19-9 levels. This scoring system was first proposed in 2004. Patients with gallbladder cancer were enrolled onto the testing sample for TMHSS to ascertain its validity. A total of 335 consecutive patients with gallbladder cancer who sought care at the Tata Memorial Hospital between May 1, 2005, and December 31, 2006, were studied. Treatment was suggested on the basis of current existing protocols. Each patient was assigned a TMHSS score, and the treatment decision taken was compared with the algorithm generated for each individual score. Concurrence of the decision taken with the score generated algorithm was tested by the Kendall tau-b test.
Ordinal-by-ordinal analysis of the value of the test was .75, which showed excellent concurrence and a statistically significant P value (P < .0001).
TMHSS provides an excellent correlative treatment plan for patients with gallbladder cancer. It has the potential to reduce unnecessary surgical explorations and to direct patients to the ideal treatment strategy, thereby offering a degree of prognostication.
[Show abstract][Hide abstract] ABSTRACT: Six Sigma is a 'process excellence' tool targeting continuous improvement achieved by providing a methodology for improving key steps of a process. It is ripe for application into health care since almost all health care processes require a near-zero tolerance for mistakes. The aim of this study is to apply the Six Sigma methodology into a clinical surgical process and to assess the improvement (if any) in the outcomes and patient care.
The guiding principles of Six Sigma, namely DMAIC (Define, Measure, Analyze, Improve, Control), were used to analyze the impact of double stapling technique (DST) towards improving sphincter preservation rates for rectal cancer.
The analysis using the Six Sigma methodology revealed a Sigma score of 2.10 in relation to successful sphincter preservation. This score demonstrates an improvement over the previous technique (73% over previous 54%).
This study represents one of the first clinical applications of Six Sigma in the surgical field. By understanding, accepting, and applying the principles of Six Sigma, we have an opportunity to transfer a very successful management philosophy to facilitate the identification of key steps that can improve outcomes and ultimately patient safety and the quality of surgical care provided.
[Show abstract][Hide abstract] ABSTRACT: Pancreaticoduodenectomy remains the recommended procedure for periampullary and pancreatic head tumors. The dissection of the uncinate process from the superior mesenteric vessels is a key step in this surgery. We describe a modification in the existing practice of infracolic division of the jejunum in order to facilitate this step. In this modification, the duodenojejunal (DJ) flexure and the proximal jejunum are delivered into the supracolic compartment and then the jejunum is divided. This exposes the uncinate process completely and facilitates the separation from the Superior Mesenteric Artery (SMA) and the Superior Mesenteric Vein (SMV). We have successfully employed this modified technique for 33 resections since February 2004. This modification of dividing the jejunum in the supracolic compartment is based on sound anatomic and embryologic grounds. It helps in aligning the uncinate process with the jejunal mesentery thereby making the dissection of uncinate process from the superior mesenteric vessels safe and complete.
[Show abstract][Hide abstract] ABSTRACT: 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 x 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.
ANZ Journal of Surgery 06/2007; 77(5):385-9. DOI:10.1111/j.1445-2197.2007.04067.x · 1.12 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Chronic arsenic (As) poisoning is a worldwide public health problem. Effects of prolonged exposure to high levels of As in drinking water have been observed and documented in various epidemiological studies from all over the world. The non-malignant cutaneous effects of chronic exposure to inorganic As are well known. A case presenting with multiple cutaneous cancers as well as an internal lung primary in a patient exposed to toxic levels of As in the drinking water is discussed along with a review of literature.
[Show abstract][Hide abstract] ABSTRACT: In absence of randomized evidence to support safety of conservative surgery (BCT) in locally advanced breast cancer (LABC), we analyzed a cohort of 664 women with LABC treated during January 1998 to December 2002 at Tata Memorial Hospital, Mumbai, India.
All were treated with a multimodality regimen comprising of neoadjuvant chemotherapy (NACT) followed by surgery (modified radical mastectomy or BCT) and adjuvant radiotherapy and hormone therapy. The outcome was evaluated to assess safety of BCT.
71% (469/664) women responded to NACT (22% clinical CR and 49% PR) and 28.3% (188/664) underwent BCT. Positive lumpectomy margins were reported in 8.5%, with gross presence of tumor at the margins in 2.3% requiring a revision surgery. At a median follow-up of 30months, local relapse rate was 8% after BCT and 10.7% after mastectomy. The 3-year local DFS was better post-conservation than after mastectomy (87% vs 78%, P=0.02). The disease-free survival (DFS) was also superior after BCT, 72% vs 52% (P<0.001) at 3years and 62% vs 37% (P<0.001) at 5years respectively. On multivariate analysis, presence of lymphatic vascular emboli (LVE) was the major significant predictor of local recurrence (P<0.001, HR 2.52, 95% CI 1.52-4.18). DFS was better after BCT [(P<0.001, HR 2.0 (95% CI 1.38-2.91)]; shorter DFS was noted in LVE positive (HR 1.54, P=0.007) and larger residual disease after NACT (HR 1.13, P=0.001).
BCT is technically feasible and safe post neo-adjuvant chemotherapy in women with LABC with no detriment in outcome.
International Journal of Surgery (London, England) 12/2006; 4(2):106-14. DOI:10.1016/j.ijsu.2006.01.004 · 1.53 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Mammography is mandatory before breast conservation. Its limited availability in developing countries has discouraged surgeons in rural areas from practicing breast conservation. We analyzed the database of breast surgeries at our institute to investigate whether breast conservation could be safely performed if clinically feasible without the use of mammography. If mammography had not been performed in the 735 patients undergoing surgery, breast conservation could have been erroneously performed in 38 (5.17%) patients; 13 had impalpable mammographic multicentricity and 25 had extensive microcalcifications. A detailed analysis showed that this error in decision would have been detected and rectified in each of the above patients before commencement of radiotherapy. We conclude that although mammography cannot be totally excluded from the treatment algorithm for palpable breast cancer, conservative surgery can be offered in clinically suitable cases even if pre-operative mammography is not available due to limited resources in the developing world.
The Breast 11/2006; 15(5):595-600. DOI:10.1016/j.breast.2006.01.010 · 2.38 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Primary angiosarcomas of breast are rare tumors, with a fatal outcome.
We studied histological prognostic factors and c-kit expression by immunohistochemistry (IHC) in 12 angiosarcomas accessioned at a cancer referral center in India.
All patients had primary angiosarcoma; no case of secondary angiosarcoma was accessioned during the study period. Median age of patients was 24.5 years. Nine patients had intermediate grade tumors, one a well differentiated tumor and three patients had high-grade tumors. Interesting cases encountered included an epithelioid angiosarcoma and an angiosarcoma arising on the background of a biphasic tumor. Eight patients had lumpectomy, four mastectomy and two patients were given radiotherapy. Of the nine patients (seven type I/II and two high grade) with follow up, eight patients developed disseminated metastases within a year of presentation. The patient with well-differentiated angiosarcoma also died of metastasis albeit after a longer time. On IHC c-kit staining was weakly seen in two cases.
Primary angiosarcoma was fatal in young Indian women even in lower grade tumors. The low expression of c-kit on IHC suggests that targeting this protein for therapy may not be successful in treating these tumors.