Global On Line Fellowship in head and neck surgery and oncology.

The International Federation of Head and Neck Oncologic Societies and Memorial Sloan Kettering Cancer Center in New York have partnered to create the Global On Line Fellowship program, a postgraduate fellowship training opportunity for candidates all around the world who are not able to get on-site fellowship training at centers of excellence. This article delineates the successes, challenges, and future goals for the program.

Establishing a Cancer Research Consortium in Low- and Middle-Income Countries: Challenges Faced and Lessons Learned.

PURPOSE: There is an increasing effort in the global public health community to strengthen research capacity in low- and middle-income countries, but there is no consensus on how best to approach such endeavors. Successful consortia that perform research on HIV/AIDS and other infectious diseases exist, but few papers have been published detailing the challenges faced and lessons learned in setting up and running a successful research consortium. METHODS: Members of the African Research Group for Oncology (ARGO) participated in generating lessons learned regarding the foundation and maintenance of a cancer research consortium in Nigeria. RESULTS: Drawing on our experience of founding ARGO, we describe steps and key factors needed to establish a successful collaborative consortium between researchers from both high- and low-income countries. In addition, we present challenges we encountered in building our consortium, and how we managed those challenges. Although our research group is focused primarily on cancer, many of our lessons learned can be applied more widely in biomedical or public health research in low-income countries. CONCLUSIONS: As the need for cancer care in LMICs continues to grow, the ability to create sustainable, innovative, collaborative research groups will become vital. Assessing the successes and failures that occur in creating and sustaining research consortia in LMICs is important for expansion of research and training capacity in LMICs.

The Cost of Postoperative Pancreatic Fistula Versus the Cost of Pasireotide: Results from a Prospective Randomized Trial.

OBJECTIVE: The objective of this study was to determine the costs of clinically significant postoperative pancreatic fistula (POPF) and to evaluate the cost-effectiveness of routine pasireotide use. SUMMARY OF BACKGROUND DATA: We recently completed a prospective randomized trial that demonstrated an 11.7% absolute risk reduction of clinically significant POPF with use of perioperative pasireotide in patients undergoing pancreaticoduodenectomy or distal pancreatectomy [POPF: pasireotide (n = 152), 9% vs placebo (n = 148), 21%; P = 0.006]. METHODS: An institutional modeling system was utilized to obtain total direct cost estimates from the 300 patients included in the trial. This system identified direct costs of hospitalization, physician fees, laboratory tests, invasive procedures, outpatient encounters, and readmissions. Total direct costs were calculated from the index admission to 90 days after resection. Costs were converted to Medicare proportional dollars (MP$). RESULTS: Clinically significant POPF occurred in 45 of the 300 randomized patients (15%). The mean total cost for all patients was MP$23,400 (MP$8,000 - MP$202,500). The mean cost for those who developed clinically significant POPF was MP$39,700 (MP$13,800 - MP$202,500) versus MP$20,500 (MP$8,000 - MP$62,900) for those who did not (P = 0.001). The mean cost of pasireotide within the treatment group (n = 152) was MP$3,300 (MP$300 - MP$3,800). The mean cost was lower in the pasireotide (n = 152) group than the placebo (n = 148) group; however, this did not reach statistical significance (pasireotide, MP$22,800 vs placebo, MP$23,900: P = 0.571). CONCLUSIONS: The development of POPF nearly doubled the total cost of pancreatic resection. In this randomized trial, the routine use of pasireotide significantly reduced the occurrence of POPF without increasing the overall cost of care.

Outcomes of the Memorial Sloan Kettering Cancer Center International General Surgical Oncology Fellowship.

BACKGROUND: Training of foreign medical graduates in surgical oncology is an undervalued intervention for improving global cancer care. The aim of this work was to describe the design and results of a clinical training program for international surgeons from a single comprehensive cancer center. STUDY DESIGN: Of 39 international fellows trained during 20 years, 34 were surveyed about education, research, and current context of surgical practice. A citation and H-index calculation (ie h number of publications that each has at least h citations) was performed to assess scientific productivity of each graduated fellow. RESULTS: Twenty-one of 39 (54%) fellows came from countries in which English is not the primary language. Europe was the continent with the most graduates (17 of 39 [43%]), and only 5 of 39 (13%) were from Latin America. Three of 39 (8%) were women. Thirty-one of 39 graduated fellows (80%) returned to their countries of origin. The survey response rate was 73% (25 of 34). Seventeen of twenty-five (68%) work in an academic setting and 13 (52%) reported surgical oncology as their main clinical practice. Total number of citations and H-index are homogeneous among the different regions from which the fellows originated, with a median of 165 citations and median H-index of 5. CONCLUSIONS: The International General Surgical Oncology Fellowship has successfully trained foreign surgeons for academic practice in surgical oncology. Most of the graduates have returned to their country of origin and contributed to education and research there.

Global cancer surgery: delivering safe, affordable, and timely cancer surgery.

Surgery is essential for global cancer care in all resource settings. Of the 15.2 million new cases of cancer in 2015, over 80% of cases will need surgery, some several times. By 2030, we estimate that annually 45 million surgical procedures will be needed worldwide. Yet, less than 25% of patients with cancer worldwide actually get safe, affordable, or timely surgery. This Commission on global cancer surgery, building on Global Surgery 2030, has examined the state of global cancer surgery through an analysis of the burden of surgical disease and breadth of cancer surgery, economics and financing, factors for strengthening surgical systems for cancer with multiple-country studies, the research agenda, and the political factors that frame policy making in this area. We found wide equity and economic gaps in global cancer surgery. Many patients throughout the world do not have access to cancer surgery, and the failure to train more cancer surgeons and strengthen systems could result in as much as US $6.2 trillion in lost cumulative gross domestic product by 2030. Many of the key adjunct treatment modalities for cancer surgery--e.g., pathology and imaging--are also inadequate. Our analysis identified substantial issues, but also highlights solutions and innovations. Issues of access, a paucity of investment in public surgical systems, low investment in research, and training and education gaps are remarkably widespread. Solutions include better regulated public systems, international partnerships, super-centralisation of surgical services, novel surgical clinical trials, and new approaches to improve quality and scale up cancer surgical systems through education and training. Our key messages are directed at many global stakeholders, but the central message is that to deliver safe, affordable, and timely cancer surgery to all, surgery must be at the heart of global and national cancer control planning.

Timing of elective surgery as a perioperative outcome variable: analysis of pancreaticoduodenectomy.

OBJECTIVES: The timing of major elective operations is a potentially important but rarely examined outcome variable. This study examined elective pancreaticoduodenectomy (PD) timing as a perioperative outcome variable. METHODS: Consecutive patients submitted to PD were identified. Determinants of 90-day morbidity (prospectively graded and tracked), anastomotic leak or fistula, and mortality, including operation start time (time of day), day of week and month, were assessed in univariate and multivariate analyses. Operation start time was analysed as a continuous and a categorical variable. RESULTS: Of the 819 patients identified, 405 (49.5%) experienced one or more complications (total number of events = 684); 90-day mortality was 3.5%. On multivariate analysis, predictors of any morbidity included male gender (P = 0.009) and estimated blood loss (P = 0.017). Male gender (P = 0.002), benign diagnosis (P = 0.002), presence of comorbidities (P = 0.002), American Society of Anesthesiologists (ASA) score (P = 0.025), larger tumour size (P = 0.013) and positive resection margin status (P = 0.005) were associated with the occurrence of anastomotic leak or fistula. Cardiac and pulmonary comorbidities were the only variables associated with 90-day mortality. Variables pertaining to procedure scheduling were not associated with perioperative morbidity or mortality. Operation start time was not significant when analysed as a continuous or a categorical variable, or when stratified by surgeon. CONCLUSIONS: Perioperative outcome after PD is determined by patient, disease and operative factors and does not appear to be influenced by procedure timing.

Comparison of disease-specific survival in the United States and Korea after resection for early-stage node-negative gastric carcinoma.

BACKGROUND AND OBJECTIVES: Disease-specific survival (DSS) for GC patients differs in Eastern and Western countries. The aim is to compare outcomes of US and Korean patients following resection of early-stage, node-negative gastric carcinoma (GC). METHODS: All patients (1995-2005) with T1N0 gastric carcinoma, excluding gastroesophageal tumors, were evaluated. DSS was compared by adjusting for prognostic variables from an internationally validated GC nomogram. RESULTS: The cohort included 598 Korean patients and 159 US patients. Age and BMI were significantly higher in US patients. Distal tumor location was more frequent in Korea (60% vs. 52%) and proximal location in the US (19% vs. 5%, P < 0.0001). Five-year DSS did not differ significantly between Korea and the US. After multivariate analysis, DSS of Korean patients persisted, with no significant differences when compared to US patients (HR = 1.2, 95% CI: 0.3-5.2, P = 0.83). CONCLUSIONS: Despite widespread speculations that GC differs in the East and West, when we compare similarly staged, node-negative GC patients, survival did not differ significantly between Korea and the US. This suggests that GC is a heterogeneous disease and when similar subtypes of gastric cancer are compared, these differences disappear. This study suggests more similarities than previously hypothesized between US and Korean GC patients.

Cancer surgery in low-income countries: an unmet need.

OBJECTIVES: To describe the surgical oncology experience at a major regional hospital in Malawi and to identify barriers to improved outcomes. DESIGN: Retrospective review of operating logbooks from a single tertiary referral center. SETTING: Major tertiary referral center (Kamuzu Central Hospital) in Lilongwe, Malawi, in sub-Saharan Africa. PATIENTS: Patients were identified with a suspected diagnosis of cancer from January 1, 2004, through March 7, 2007. MAIN OUTCOME MEASURES: Cancer cases were classified according to patient demographic characteristics, disease location, and therapeutic intent. The Malawi data were compared with US data from the Surveillance Epidemiology and End Results database. RESULTS: A malignant diagnosis was suspected in 255 of the 1440 patients undergoing a major resection (17.8%) (mean patient age, 53 years). The most common cancers in males were prostate, esophageal, and gastric. In females, the most common cancers were breast, colon, and esophageal. Many of the procedures were performed with palliative intent. CONCLUSIONS: Cancer surgery comprises a significant proportion of the surgical caseload in low-income countries. Patients often present with late-stage, inoperable cancer. The participation of the surgical community is critical for addressing barriers to effective cancer care.

Delivering affordable cancer care in high-income countries.

The burden of cancer is growing, and the disease is becoming a major economic expenditure for all developed countries. In 2008, the worldwide cost of cancer due to premature death and disability (not including direct medical costs) was estimated to be US$895 billion. This is not simply due to an increase in absolute numbers, but also the rate of increase of expenditure on cancer. What are the drivers and solutions to the so-called cancer-cost curve in developed countries? How are we going to afford to deliver high quality and equitable care? Here, expert opinion from health-care professionals, policy makers, and cancer survivors has been gathered to address the barriers and solutions to delivering affordable cancer care. Although many of the drivers and themes are specific to a particular field-eg, the huge development costs for cancer medicines-there is strong concordance running through each contribution. Several drivers of cost, such as over-use, rapid expansion, and shortening life cycles of cancer technologies (such as medicines and imaging modalities), and the lack of suitable clinical research and integrated health economic studies, have converged with more defensive medical practice, a less informed regulatory system, a lack of evidence-based sociopolitical debate, and a declining degree of fairness for all patients with cancer. Urgent solutions range from re-engineering of the macroeconomic basis of cancer costs (eg, value-based approaches to bend the cost curve and allow cost-saving technologies), greater education of policy makers, and an informed and transparent regulatory system. A radical shift in cancer policy is also required. Political toleration of unfairness in access to affordable cancer treatment is unacceptable. The cancer profession and industry should take responsibility and not accept a substandard evidence base and an ethos of very small benefit at whatever cost; rather, we need delivery of fair prices and real value from new technologies.

Staging laparoscopy in the management of gastric cancer: a population-based analysis.

BACKGROUND: Staging laparoscopy can detect radiographically occult peritoneal metastases and prevent futile laparotomy in patients with gastric adenocarcinoma. We sought to assess the use of staging laparoscopy for gastric adenocarcinoma in a cohort of older patients and to compare outcomes after laparoscopy alone with nontherapeutic laparotomy. STUDY DESIGN: Using Surveillance, Epidemiology and End Results (SEER) population-based cancer registry data linked with Medicare claims, we identified patients aged 65 or older diagnosed with gastric adenocarcinoma between 1998 and 2005. We defined staging laparoscopy as a laparoscopic procedure from 1 month before the date of diagnosis until death and futile laparotomy as a laparotomy in the absence of a therapeutic intervention. We examined trends in the use of staging laparoscopy and compared outcomes between patients who underwent staging laparoscopy alone and those who had a futile laparotomy. RESULTS: Of 11,759 patients with gastric adenocarcinoma, 6,388 (54.3%) had at least 1 surgical procedure. Staging laparoscopy was performed in 506 (7.9%) patients who had any surgery, and 151 (29.8%) of these patients did not have a subsequent therapeutic intervention. Patients who underwent staging laparoscopy alone had a significantly lower rate of in-hospital mortality (5.3% vs 13.1%, p < 0.001) and shorter length of hospitalization (2 vs 10 days, p < 0.001) than patients who had futile laparotomy. CONCLUSIONS: Our findings in this large, population-based cohort suggest that staging laparoscopy is used infrequently in the management of older patients with gastric adenocarcinoma. Increased use of staging laparoscopy could reduce the substantial morbidity and mortality associated with nontherapeutic laparotomy.

Adequate lymph node assessment for extrahepatic bile duct adenocarcinoma.

OBJECTIVE: To examine the importance of adequate lymph node sampling in staging of extrahepatic bile duct cancer (EHBDCA). SUMMARY OF BACKGROUND DATA: The American Joint Committee on Cancer staging manual (sixth edition) states that histologic examination of at least 3 lymph nodes is required for adequate N stage determination for EHBDCA. This recommendation has not been validated; however, there has been no comparative assessment of the proximal versus distal bile duct cancer. METHODS: A total of 257 patients (144 hilar cholangiocarcinoma [HCCA] and 113 distal bile duct adenocarcinoma [DBDCA]) who underwent curative intent resection (1987-2007) were analyzed; patients with gallbladder cancer were excluded. Final disease staging, including lymph node status and total number of nodes examined (total lymph node count), was obtained from the final pathology report. Differences in disease-specific survival, according to nodal status, were compared using the log-rank test. R1 resections (n = 51) were excluded from this analysis. RESULTS: Metastasis to regional lymph nodes was noted in 89 patients (34.6%) and was an independent prognostic factor of poor survival (median disease-specific survival N0 vs. N1: 53.5 vs. 19.3 months, P < 0.0001, hazard ratio = 2.1 [95% CI: 1.4-3.2]). The median total lymph node count was 6 (range: 0-42), and was significantly lower for HCCA compared with DBDCA (median = 3 [range: 0-16] vs. 12 [range: 1-42], P < 0.001, respectively). For the entire cohort, patients who underwent R0 resection and were classified as N0, based on total lymph node count <11, had a disease-specific survival that was significantly worse than that of patients classified as N0 based on total lymph node count >or=11 (52.6 +/- 9.8 months vs. not reached, P = 0.008). The estimated optimal total lymph node count for HCCA differed from that of DBDCA (n = 7 vs. n = 11, respectively). CONCLUSIONS: Adequate lymph nodes assessment of EHBDCA, based on the current AJCC recommendations, results in understaging of these tumors. With respect to the optimal total lymph node count, HCCA, and DBDCA should be considered separately.

Low-grade myxofibrosarcoma: a clinicopathologic analysis of 49 cases treated at a single institution with simultaneous assessment of the efficacy of 3-tier and 4-tier grading systems.

Grading of myxofibrosarcoma (MFS) is contentious and based on a variety of factors, such as the percentage of myxoid or solid areas, tumor necrosis, mitotic counts, and so on. These factors are often used in combination for different grading schemes, which have not been uniformly evaluated by consistent criteria for patients treated and prospectively followed up at a single institution. Because only a subset of low-grade (LG) MFS will progress to high grade and metastasize after relentless local recurrences, we analyze various histologic parameters and grading methods to identify prognostic predictors of the LGMFS. Forty-nine cases were classified as LGMFS after review, by using > or =30% of myxoid component, but < or =20% of solid areas and only focal, < or =10%, of tumor necrosis as cutoffs, as modified from a 2-tier system that is used in our hospital. These cases were also graded in parallel by French Federation of Cancer Centers Sarcoma Group (FNCLCC) 3-tier and 4-tier grading schemes. The study cohort consisted of 26 men and 23 women, with a median age of 60.5 years. Nineteen cases were superficial, and 30 were deep seated, with the most common site being the lower limb (57%), followed by the upper limb (31%), trunk (8%), and head and neck (4%). The primary tumors ranged from 1.5 to 24 cm in size. Solid areas (5% to 20%) were seen in 23 cases, tumor necrosis (5% to 10%) was observed in 4 cases, and a predominant myxoid area (> or =75%) was noted in 22 cases. Mitotic activity ranged from 0 to 16 (median, 2) per 10 HPF. Comparing FNCLCC 3-tier versus 4-tier grading, respectively, 26 versus 10 tumors were classified as grade I, and 23 versus 39, as grade II, with 16 cases (33%) graded discordantly by 2 schemes. A median follow-up of 55 months in 49 patients (range, 9 to 171 months) revealed local recurrence occurring in 28 patients (57%), 15 and 7 of which developed multiple local recurrences and distant metastases, respectively. There was only 1 case with pulmonary metastasis without a prior local recurrence. Currently, 33 patients are alive with no evidence of disease, 4 are alive with disease, 9 are dead of disease, and 3 are dead of unknown causes. The 5-year recurrence-free survival, metastasis-free survival (MeFS), and disease-specific mortality (DSM) rates were 41%, 90%, and 4.4%, respectively. Size of larger than 5 cm (P = 0.032), tumor necrosis (P = 0.033), and < 75% of myxoid area (P = 0.042) were significant risk factors for DSM; the former two (P = 0.011 for size larger than 5 cm, P = 0.038 for necrosis) were also significantly related to MeFS. Both FNCLCC 3-tier and 4-tier schemes failed to show a significantly better outcome in grade I LGMFS than grade II lesions with respect to all 3 endpoints. In conclusion, our data statistically validated the previous impression that even the blandest LGMFS still carries a recurrent potential that cannot be foreseen by either different grading schemes or other clinicopathologic parameters. However, DSM rate is significantly related to tumor necrosis, large size, and decreased myxoid area. Tumors having necrosis or exceeding 5 cm are at significant risk of metastatic relapse.

Cost-effectiveness of pulmonary resection and systemic chemotherapy in the management of metastatic soft tissue sarcoma: a combined analysis from the University of Texas M. D. Anderson and Memorial Sloan-Kettering Cancer Centers.

BACKGROUND: We sought to determine the cost-effectiveness of different treatment strategies for patients with pulmonary metastases from soft tissue sarcoma. METHODS: We constructed a decision tree to model the outcomes of 4 treatment strategies for patients with pulmonary metastases from soft tissue sarcoma: pulmonary resection, systemic chemotherapy, pulmonary resection and systemic chemotherapy, and no treatment. Data from 1124 patients with pulmonary metastases from soft tissue sarcoma were used to estimate disease-specific survival for pulmonary resection and no treatment. Outcomes of systemic chemotherapy and pulmonary resection and of systemic chemotherapy were estimated by assuming a 12-month improvement in disease-specific survival with chemotherapy; this was done on the basis of the widely held but unproven assumption that chemotherapy provides a survival benefit in patients with metastatic soft tissue sarcoma. Direct costs were examined for a series of patients who underwent protocol-based pulmonary resection or doxorubicin/ifosfamide-based chemotherapy. RESULTS: The mean cost of pulmonary resection was 20,339 dollars per patient; the mean cost of 6 cycles of chemotherapy was 99,033 dollars. Compared with no treatment and assuming a 12-month survival advantage with chemotherapy, the incremental cost-effectiveness ratio was 14,357 dollars per life-year gained for pulmonary resection, 104,210 dollars per life-year gained for systemic chemotherapy, and 51,159 dollars per life-year gained for pulmonary resection and systemic chemotherapy. Compared with pulmonary resection, the incremental cost-effectiveness ratio of pulmonary resection and systemic chemotherapy was 108,036 dollars per life-year gained. Sensitivity analyses showed that certain patient and tumor features, as well as the assumed benefit of chemotherapy, affected cost-effectiveness. CONCLUSIONS: For patients with pulmonary metastases from soft tissue sarcoma who were surgical candidates, pulmonary resection was the most cost-effective treatment strategy evaluated. Even with favorable assumptions regarding its clinical benefit, systemic chemotherapy alone, compared with no treatment, was not a cost-effective treatment strategy for these patients.

Prospective functional voice assessment in patients undergoing thyroid surgery.

OBJECTIVE: To analyze voice function before and after thyroidectomy for patients with normal preoperative voice using a standardized multidimensional voice assessment protocol. SUMMARY BACKGROUND DATA: The natural history of post-thyroidectomy voice disturbances for patients with preserved laryngeal nerve function has not been systematically studied and characterized with the intent of using the data for postoperative voice rehabilitation. METHODS: During a prospective single-arm study, patients with normal voice underwent functional voice testing using a standardized voice grading scale and a battery of acoustic, aerodynamic, glottographic, and videostroboscopic tests before, 1 week after, and 3 months after thyroidectomy. Differences in observed sample means were evaluated using analysis of covariance or t test; categorical data was analyzed using the Fisher exact or chi-square test. RESULTS: Fifty-four patients were enrolled; 50 and 46 were evaluable at 1 week and 3 months, respectively. No patient developed recurrent laryngeal nerve injury; one had superior laryngeal nerve injury. Fifteen (30%) patients reported early subjective voice change and seven (14%) reported late (3-month) subjective voice change. Forty-two (84%) patients had significant objective change in at least one voice parameter. Six (12%) had significant alterations in more than three voice measures, of which four (67%) were symptomatic, whereas 25% with three or fewer objective changes had symptoms. Patients with persistent voice change at 3 months had an increased likelihood of multiple (more than three) early objective changes (43% vs. 7%). Early maximum phonational frequency range and vocal jitter changes from baseline were significantly associated with voice symptoms at 3 months. CONCLUSIONS: Early vocal symptoms are common following thyroidectomy and persist in 14% of patients. Multiple (more than three) objective voice changes correlate with early and late postoperative symptoms. Alterations in maximum phonational frequency range and vocal jitter predict late perceived vocal changes. Factors other than laryngeal nerve injury appear to alter post-thyroidectomy voice. The variability of patient symptoms underscores the importance of understanding the physiology of dysphonia.

High-pressure gradients generated by closed-suction surgical drainage systems.

BACKGROUND: Closed suction drains remain in widespread use in surgical practice. There have been reports of complications associated with their use. We sought to characterize the pressure-generating capacities of three commonly used closed suction drainage systems. MATERIALS AND METHODS: Three commonly used closed suction surgical drainage systems were studied: Davol Reliavac 400 Evacuator, Jackson-Pratt Closed Wound Suction Drainage System, and Snyder Hemovac 400. Each drainage system was connected to a pneumatic pressure transducer, and pressure measurements were made. Measurements were made with the drain reservoirs at varying degrees of fullness. Measurements were also made while "stripping" the drains. RESULTS: In all three systems, maximal negative pressures (-71 to -175 mm Hg) were generated with the reservoirs empty of fluid. Pressure generation by all drains decreased as the volume of fluid in the reservoir increased. In all cases, drain "stripping" was associated with a transient elevation in drain pressure (p<0.05). In two out of three drains, stripping led to a significant residual increase in static drain pressure. CONCLUSION: Closed suction drains are capable of generating high pressures that may contribute to some complications associated with their use. Closed suction drainage systems differ with regard to their generation of negative pressure.