The Groningen International Study on Sentinel nodes in Vulvar cancer (GROINSS-V)-II investigated whether inguinofemoral radiotherapy is a safe alternative to inguinofemoral lymphadenectomy (IFL) in ...vulvar cancer patients with a metastatic sentinel node (SN).
GROINSS-V-II was a prospective multicenter phase-II single-arm treatment trial, including patients with early-stage vulvar cancer (diameter < 4 cm) without signs of lymph node involvement at imaging, who had primary surgical treatment (local excision with SN biopsy). Where the SN was involved (metastasis of any size), inguinofemoral radiotherapy was given (50 Gy). The primary end point was isolated groin recurrence rate at 24 months. Stopping rules were defined for the occurrence of groin recurrences.
From December 2005 until October 2016, 1,535 eligible patients were registered. The SN showed metastasis in 322 (21.0%) patients. In June 2010, with 91 SN-positive patients included, the stopping rule was activated because the isolated groin recurrence rate in this group went above our predefined threshold. Among 10 patients with an isolated groin recurrence, nine had SN metastases > 2 mm and/or extracapsular spread. The protocol was amended so that those with SN macrometastases (> 2 mm) underwent standard of care (IFL), whereas patients with SN micrometastases (≤ 2 mm) continued to receive inguinofemoral radiotherapy. Among 160 patients with SN micrometastases, 126 received inguinofemoral radiotherapy, with an ipsilateral isolated groin recurrence rate at 2 years of 1.6%. Among 162 patients with SN macrometastases, the isolated groin recurrence rate at 2 years was 22% in those who underwent radiotherapy, and 6.9% in those who underwent IFL (
= .011). Treatment-related morbidity after radiotherapy was less frequent compared with IFL.
Inguinofemoral radiotherapy is a safe alternative for IFL in patients with SN micrometastases, with minimal morbidity. For patients with SN macrometastasis, radiotherapy with a total dose of 50 Gy resulted in more isolated groin recurrences compared with IFL.
Background
Quality assurance is acknowledged as a crucial factor in the assessment of oncological surgical care. The aim of this study was to develop a composite measure of multiple outcome ...parameters defined as ‘textbook outcome’, to assess quality of care for patients undergoing oesophagogastric cancer surgery.
Methods
Patients with oesophagogastric cancer, operated on with the intent of curative resection between 2011 and 2014, were identified from a national database (Dutch Upper Gastrointestinal Cancer Audit). Textbook outcome was defined as the percentage of patients who underwent a complete tumour resection with at least 15 lymph nodes in the resected specimen and an uneventful postoperative course, without hospital readmission. Hospital variation in textbook outcome was analysed after adjustment for case‐mix factors.
Results
In total, 2748 patients with oesophageal cancer and 1772 with gastric cancer were included in this study. A textbook outcome was achieved in 29·7 per cent of patients with oesophageal cancer and 32·1 per cent of those with gastric cancer. Adjusted textbook outcome rates varied from 8·5 to 52·4 per cent between hospitals. The outcome parameter ‘at least 15 lymph nodes examined’ had the greatest negative impact on a textbook outcome both for patients with oesophageal cancer and for those with gastric cancer.
Conclusion
Most patients did not achieve a textbook outcome and there was wide variation between hospitals.
Novel approach to quality assessment
Abstract Context The introduction of novel imaging modalities has increased the detection of oligometastatic prostate cancer (PCa) recurrence, potentially justifying the use of a metastasis-directed ...therapy (MDT) with surgery or radiotherapy (RT) rather than a systemic approach. Objective To perform a systematic review of MDT for oligometastatic PCa recurrence. Evidence acquisition This systematic review was performed according to Preferred Reporting Items for Systematic Reviews and Meta-analysis guidelines. We searched the Medline and Embase databases from 1946 to February 2014 for studies reporting on biochemical or clinical progression and/or toxicity or complications of MDT (RT or surgery). Reports were excluded if these end points could not be ascertained or separately analysed, or if insufficient details were provided. Methodological quality was assessed using an 18-item validated quality appraisal tool for case series. Evidence synthesis Fifteen single-arm case series reporting on a total of 450 patients met the inclusion criteria. Seven studies were considered of acceptable quality. Oligometastatic PCa recurrence was diagnosed with positron emission tomography with coregistered computed tomography in most of the patients (98%). Nodal, bone, and visceral metastases were treated in 78%, 21%, and 1%, respectively. Patients were treated with either RT (66%) or lymph node dissection (LND) (34%). Adjuvant androgen deprivation was given in 61% of patients ( n = 275). In the case of nodal metastases, prophylactic nodal irradiation was administered in 49% of patients ( n = 172). Overall, 51% of patients were progression free 1–3 yr after salvage MDT, with most of them receiving adjuvant treatment. For RT, grade 2 toxicity was observed in 8.5% of patients, with one case of grade 3 toxicity. In the case of LND, 11% and 12% of grade 2 and grade 3 complications, respectively, were reported. Conclusions MDT is a promising approach for oligometastatic PCa recurrence, but the low level of evidence generated by small case series does not allow extrapolation to a standard of care. Patient summary We performed a systematic review to assess complications and outcomes of treating oligometastatic prostate cancer recurrence with surgery or radiotherapy. We concluded that although this approach is promising, it requires validation in randomised controlled trials.
Abstract Objectives The study purpose was to compare hysterectomy and lymphadenectomy completed via robotic assistance, laparotomy, and laparoscopy for endometrial cancer staging with respect to ...operative and peri-operative outcomes, complications, adequacy of staging, and cost. Methods One hundred and ten patients underwent hysterectomy with bilateral salpingo-oophorectomy, pelvic and para-aortic lymphadenectomy for endometrial cancer staging. All cases were performed by a single surgeon, at a single institution (40 robotic, 40 laparotomy, and 30 laparoscopic) and were retrospectively reviewed to compare demographics and peri-operative variables including, operative time, estimated blood loss, lymph node count, hospital stay, complications, and return to normal activity. Additionally, a cost comparison between all three modalities was performed. Results Patients undergoing robotic assisted hysterectomy and staging experienced longer operative time than the laparotomy cohort with no difference in comparison to the laparoscopic cohort (184 min, 108.6 min, 171 min, p < 0.0001, p = 0.14). Estimated blood loss was significantly reduced for the robotic cohort in comparison to the laparotomy cohort and comparable to laparoscopic cohort (166 cc, 316 cc, 253 cc, p = 0.01, p = 0.25). The complication rate was lowest in the robotic cohort (7.5%) relative to the laparotomy (27.5%) and laparoscopic cohorts (20%) ( p = 0.015, p = 0.03). Average return to normal activity for the robotic patients was significantly shorter than those undergoing laparotomy (24.1 days versus 52 days, p < 0.0001) and those undergoing laparoscopy (31.6 days, p = 0.005). Lymph node retrieval did not differ between the 3 groups (robotic 17 nodes, laparotomy 14 nodes, laparoscopic 17 nodes). The total average cost for hysterectomy with staging completed via laparotomy was $12,943.60, for standard laparoscopy $7569.80, and for robotic assistance $8212.00. The difference in cost between laparotomy and robotic cohorts was significant p = 0.0001 while there was no statistically significant difference in cost between laparoscopy and robotic cohorts p = 0.06. Conclusions Robotic hysterectomy provides comparable node retrieval to laparotomy and laparoscopic procedures in the case of the experienced laparoscopic surgeon. While robotic hysterectomy takes longer to perform than hysterectomy completed via laparotomy, it is equivalent to laparoscopic hysterectomy and provides the patient with a more expeditious return to normal activity with reduced post-operative morbidity. Additionally, the average cost for hysterectomy and staging was highest for laparotomy, followed by robotic, and least for standard laparoscopy.
AIM:To assess the effects of 3-field lymphadenectomy for esophageal carcinoma.METHODS:We conducted a computerized literature search of the Pub Med,Cochrane Controlled Trials Register,and EMBASE ...databases from their inception to present.Randomized controlled trials(RCTs)or observational epidemiological studies(cohort studies)that compared the survival rates and/or postoperative complications between 2-field lymphadenectomy(2FL)and3-field lymphadenectomy(3FL)for esophageal carcinoma with R0 resection were included.Meta-analysis was conducted using published data on 3FL vs 2FL in esophageal carcinoma patients.End points were 1-,3-,and 5-year overall survival rates and postoperativecomplications,including recurrent nerve palsy,anastomosis leak,pulmonary complications,and chylothorax.Subgroup analysis was performed on the involvement of recurrent laryngeal lymph nodes.RESULTS:Two RCTs and 18 observational studies with over 7000 patients were included.There was a clear benefit for 3FL in the 1-(RR=1.16;95%CI:1.09-1.24;P<0.01),3-(RR=1.44;95%CI:1.19-1.75;P<0.01),and 5-year overall survival rates(RR=1.37;95%CI:1.18-1.59;P<0.01).For postoperative complications,3FL was associated with significantly more recurrent nerve palsy(RR=1.43;95%CI:1.28-1.60;P=0.02)and anastomosis leak(RR=1.26;95%CI:1.05-1.52;P=0.09).In contrast,there was no significant difference for pulmonary complications(RR=0.93;95%CI:0.75-1.16,random-effects model;P=0.27)or chylothorax(RR=0.77;95%CI:0.32-1.85;P=0.69).CONCLUSION:This meta-analysis shows that 3FL improves overall survival rate but has more complications.Because of the high heterogeneity among outcomes,definite conclusions are difficult to draw.
Background
It is still unclear whether D2 lymphadenectomy improves the survival of patients with gastric cancer and should therefore be performed routinely or selectively. The aim of this multicentre ...randomized trial was to compare D2 and D1 lymphadenectomy in the treatment of gastric cancer.
Methods
Between June 1998 and December 2006, patients with gastric adenocarcinoma were assigned randomly to either D1 or D2 gastrectomy. Intraoperative randomization was implemented centrally by telephone. Primary outcome was overall survival; secondary endpoints were disease‐specific survival, morbidity and postoperative mortality.
Results
A total of 267 eligible patients were allocated to either D1 (133 patients) or D2 (134) resection. Morbidity (12·0 versus 17·9 per cent respectively; P = 0·183) and operative mortality (3·0 versus 2·2 per cent; P = 0·725) rates did not differ significantly between the groups. Median follow‐up was 8·8 (range 4·5–13·1) years for surviving patients and 2·4 (0·2–11·9) years for those who died, and was not different in the two treatment arms. There was no difference in the overall 5‐year survival rate (66·5 versus 64·2 per cent for D1 and D2 lymphadenectomy respectively; P = 0·695). Subgroup analyses showed a 5‐year disease‐specific survival benefit for patients with pathological tumour (pT) 1 disease in the D1 group (98 per cent versus 83 per cent for the D2 group; P = 0·015), and for patients with pT2–4 status and positive lymph nodes in the D2 group (59 per cent versus 38 per cent for the D1 group; P = 0·055).
Conclusion
No difference was found in overall 5‐year survival between D1 and D2 resection. Subgroup analyses suggest that D2 lymphadenectomy may be a better choice in patients with advanced disease and lymph node metastases. Registration number: ISRCTN11154654 (http://www.controlled‐trials.com).
No difference
Complete lymph node removal through conventional axillary dissection (ALND) has been standard treatment for breast cancer patients for almost a century. In the 1990s, however, and in parallel with ...the advent of the sentinel lymph node (SLN) procedure, ALND came under increasing scrutiny due to its association with significant patient morbidity. Several studies have since provided evidence to suggest omission of ALND, often in favor of axillary radiation, in selected clinically node-negative, SLN-positive patients, thus supporting the current trend in clinical practice. Clinically node-positive patients, by contrast, continue to undergo ALND in many cases, if only for the lack of studies re-assessing the indication for ALND in these patients. Hence, there is a need for a clinical trial to evaluate the optimal treatment for clinically node-positive breast cancer patients in terms of surgery and radiotherapy. The TAXIS trial is designed to fill this gap by examining in particular the value of tailored axillary surgery (TAS), a new technique for selectively removing positive lymph nodes.
In this international, multicenter, phase-III, non-inferiority, randomized controlled trial (RCT), including 34 study sites from four different countries, we plan to randomize 1500 patients to either receive TAS followed by ALND and regional nodal irradiation excluding the dissected axilla, or receive TAS followed by regional nodal irradiation including the full axilla. All patients undergo adjuvant whole-breast irradiation after breast-conserving surgery and chest-wall irradiation after mastectomy. The main objective of the trial is to test the hypothesis that treatment with TAS and axillary radiotherapy is non-inferior to ALND in terms of disease-free survival of clinically node-positive breast cancer patients in the era of effective systemic therapy and extended regional nodal irradiation. The trial was activated on 31 July 2018 and the first patient was randomized on 7 August 2018.
Designed to test the hypothesis that TAS is non-inferior to ALND in terms of curing patients and preventing recurrences, yet is significantly superior in reducing patient morbidity, this trial may establish a new worldwide treatment standard in breast cancer surgery. If found to be non-inferior to standard treatment, TAS may significantly contribute to reduce morbidity in breast cancer patients by avoiding surgical overtreatment.
ClinicalTrials.gov, ID: NCT03513614. Registered on 1 May 2018. www.kofam.ch , ID: NCT03513614 . Registered on 17 June 2018. EudraCT No.: 2018-000372-14.
Background
Surgery is an important part of the management of oral cavity cancer with regard to both the removal of the primary tumour and removal of lymph nodes in the neck. Surgery is less ...frequently used in oropharyngeal cancer. Surgery alone may be treatment for early‐stage disease or surgery may be used in combination with radiotherapy, chemotherapy and immunotherapy/biotherapy. There is variation in the recommended timing and extent of surgery in the overall treatment regimens of people with these cancers. This is an update of a review originally published in 2007 and first updated in 2011.
Objectives
To determine which surgical treatment modalities for oral and oropharyngeal cancers result in increased overall survival, disease‐free survival and locoregional control and reduced recurrence. To determine the implication of treatment modalities in terms of morbidity, quality of life, costs, hospital days of treatment, complications and harms.
Search methods
Cochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 20 December 2017), the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 11), MEDLINE Ovid (1946 to 20 December 2017) and Embase Ovid (1980 to 20 December 2017). We searched the US National Institutes of Health Trials Registry (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform for ongoing trials. There were no restrictions on the language or date of publication.
Selection criteria
Randomised controlled trials where more than 50% of participants had primary tumours of the oral cavity or oropharynx, or where separate data could be extracted for these participants, and that compared two or more surgical treatment modalities, or surgery versus other treatment modalities.
Data collection and analysis
Two or more review authors independently extracted data and assessed risk of bias. We contacted study authors for additional information as required. We collected adverse events data from included studies.
Main results
We identified five new trials in this update, bringing the total number of included trials to 12 (2300 participants; 2148 with cancers of the oral cavity). We assessed four trials at high risk of bias, and eight at unclear. None of the included trials compared different surgical approaches for the excision of the primary tumour. We grouped the trials into seven main comparisons.
Future research may change the findings as there is only very low‐certainty evidence available for all results.
Five trials compared elective neck dissection (ND) with therapeutic (delayed) ND in participants with oral cavity cancer and clinically negative neck nodes, but differences in type of surgery and duration of follow‐up made meta‐analysis inappropriate in most cases. Four of these trials reported overall and disease‐free survival. The meta‐analyses of two trials found no evidence of either intervention leading to greater overall survival (hazard ratio (HR) 0.84, 95% confidence interval (CI) 0.41 to 1.72; 571 participants), or disease‐free survival (HR 0.73, 95% CI 0.25 to 2.11; 571 participants), but one trial found a benefit for elective supraomohyoid ND compared to therapeutic ND in overall survival (RR 0.40, 95% CI 0.19 to 0.84; 67 participants) and disease‐free survival (HR 0.32, 95% CI 0.12 to 0.84; 67 participants). Four individual trials assessed locoregional recurrence, but could not be meta‐analysed; one trial favoured elective ND over therapeutic delayed ND, while the others were inconclusive.
Two trials compared elective radical ND with elective selective ND, but we were unable to pool the data for two outcomes. Neither study found evidence of a difference in overall survival or disease‐free survival. A single trial found no evidence of a difference in recurrence.
One trial compared surgery plus radiotherapy with radiotherapy alone, but data were unreliable because the trial stopped early and there were multiple protocol violations.
One trial comparing positron‐emission tomography‐computed tomography (PET‐CT) following chemoradiotherapy (with ND only if no or incomplete response) versus planned ND (either before or after chemoradiotherapy), showed no evidence of a difference in mortality (HR 0.92, 95% CI 0.65 to 1.31; 564 participants). The trial did not provide usable data for the other outcomes.
Three single trials compared: surgery plus adjunctive radiotherapy versus chemoradiotherapy; supraomohyoid ND versus modified radical ND; and super selective ND versus selective ND. There were no useable data from these trials.
The reporting of adverse events was poor. Four trials measured adverse events. Only one of the trials reported quality of life as an outcome.
Authors' conclusions
Twelve randomised controlled trials evaluated ND surgery in people with oral cavity cancers; however, the evidence available for all comparisons and outcomes is very low certainty, therefore we cannot rely on the findings. The evidence is insufficient to draw conclusions about elective ND of clinically negative neck nodes at the time of removal of the primary tumour compared to therapeutic (delayed) ND. Two trials combined in meta‐analysis suggested there is no difference between these interventions, while one trial (which evaluated elective supraomohyoid ND) found that it may be associated with increased overall and disease‐free survival. One trial found elective ND reduced locoregional recurrence, while three were inconclusive. There is no evidence that radical ND increases overall or disease‐free survival compared to more conservative ND surgery, or that there is a difference in mortality between PET‐CT surveillance following chemoradiotherapy versus planned ND (before or after chemoradiotherapy). Reporting of adverse events in all trials was poor and it was not possible to compare the quality of life of people undergoing different surgical treatments.
To evaluate the incidence and risk factors for lymphedema associated with surgery for gynecologic malignancies on GOG study 244.
Women undergoing a lymph node dissection for endometrial, cervical, or ...vulvar cancer were eligible for enrollment. Leg volume was calculated from measurements at 10-cm intervals starting 10 cm above the bottom of the heel to the inguinal crease. Measurements were obtained preoperatively and postoperatively at 4–6 weeks, and at 3-, 6-, 9-, 12-, 18-, and 24- months. Lymphedema was defined as a limb volume change (LVC) ≥10% from baseline and categorized as mild: 10–19% LVC; moderate: 20–40% LVC; or severe: >40% LVC. Risk factors associated with lymphedema were also analyzed.
Of 1054 women enrolled on study, 140 were inevaluable due to inadequate measurements or eligibility criteria. This left 734 endometrial, 138 cervical, and 42 vulvar patients evaluable for LVC assessment. Median age was 61 years (range, 28–91) in the endometrial, 44 years (range, 25–83) in the cervical, and 58 years (range, 35–88) in the vulvar group. The incidence of LVC ≥10% was 34% (n = 247), 35% (n = 48), and 43% (n = 18), respectively. The peak incidence of lymphedema was at the 4–6 week assessment. Logistic regression analysis showed a decreased risk with advanced age (p = 0.0467). An exploratory analysis in the endometrial cohort showed an increased risk with a node count >8 (p = 0.033).
For a gynecologic cancer, LVC decreased with age greater than 65, but increased with a lymph node count greater than 8 in the endometrial cohort. There was no association with radiation or other risk factors.
•Lymphedema as defined by volume change ≥10% was found in 34% of endometrial, 35% of cervical, and 43% of vulvar patients.•Regression analysis showed risk decreased with advanced age (p = 0.0467) and increased with a node count >8 (p = 0.033).•Increase risk of lymphedema was not associated with radiation, advanced stage or other commonly reported risk factors.•Final conclusions were weakened by 50% lost to follow-up and discrepancies in measurements identified in 32% of patients.
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