|Year : 2019 | Volume
| Issue : 2 | Page : 152-157
Unplanned excision in soft-tissue sarcomas – Is it the unkindest cut of all?
Nizamudheen M Pareekutty, Abhay K Kattepur, John J Alapatt, B Satheesan
Department of Surgical Oncology, Malabar Cancer Centre, Thalassery, Kerala, India
|Date of Web Publication||20-Dec-2019|
Abhay K Kattepur
Department of Surgical Oncology, Malabar Cancer Centre, Kodiyeri, Thalassery - 670 103, Kerala
Source of Support: None, Conflict of Interest: None
Objectives: The main objective was to study the oncological outcomes of patients undergoing unplanned (uP) excision for soft-tissue sarcomas (STS) at a tertiary cancer institute.
Materials and Methods: This was a retrospective analysis of patients of STS from June 2009 to December 2015. Patients who had undergone uP surgery outside followed by definitive surgery were compared to those undergoing surgery at our center. The oncological outcomes, including overall survival (OS) and disease-free survival (DFS), were analyzed using Kaplan–Meier method.
Results: A total of 51 patients were included: 22 (43.13%) in the P group and 29 in the uP group. At a median follow-up of 44 months, the estimated 5-year OS was higher in the uP group (92.4% vs. 60.6%, P = 0.032) compared to the planned group. However, there was no difference in DFS.
Conclusions: Although survival of patients undergoing uP excision outside was better, this could be related to more favorable histology, grade, and smaller tumor size at presentation.
Keywords: Outcomes, soft-tissue sarcoma, survival, unplanned excision
|How to cite this article:|
Pareekutty NM, Kattepur AK, Alapatt JJ, Satheesan B. Unplanned excision in soft-tissue sarcomas – Is it the unkindest cut of all?. Cancer Res Stat Treat 2019;2:152-7
|How to cite this URL:|
Pareekutty NM, Kattepur AK, Alapatt JJ, Satheesan B. Unplanned excision in soft-tissue sarcomas – Is it the unkindest cut of all?. Cancer Res Stat Treat [serial online] 2019 [cited 2020 Aug 4];2:152-7. Available from: http://www.crstonline.com/text.asp?2019/2/2/152/273687
| Introduction|| |
The adage from the Hippocratic Oath “Primum non nocere” translating as, “First, do no harm,” is perhaps the most fitting rule in the treatment of soft-tissue sarcoma (STS). STSs are rare tumors, with an incidence ranging from 1 to 5/100,000 per year. A soft-tissue lump is 100–300 times more likely to be benign than malignant.,, This is the reason why a soft-tissue tumor often undergoes excision without a proper preoperative imaging, biopsy, or planning by an unwary surgeon.
An unplanned (uP) excision is an excisional biopsy or resection of a soft-tissue lesion without a preoperative core biopsy and/or imaging. There is little or no attention paid to obtaining negative/clear margins as the surgeon does not anticipate the possibility of malignancy in this scenario. These uP excisions are important as positive or close margins stemming from such surgeries could translate into increased local recurrence rates, often varying from 30% to 90%.,,
uP excision of the STS was first reported by Guiliano et al. These excisions have acquired an eponym termed, “Whoops! Procedure” indicating the surprise and distress that the surgeon experiences, after the pathologist reports a malignant neoplasm in a postoperative specimen.
The manifold problems with uP excisions include the contamination of the various tissue layers around the tumor with malignant cells, the need for a second or additional surgical procedures, the delay in institution of adjuvant treatment, especially radiotherapy with or without chemotherapy, a small but definite risk of local recurrence, and occasionally, the need to amputate the affected limb to achieve oncological results in cases where the prior scar is inappropriate, or there is tumor contamination around the major neurovascular bundle.
According to Hoshi et al., uP excisions are characterized by the use of transverse incisions for tumor extirpation, incisions close to joints leading to contamination of joint cavities, poor placement of drains, development of large hematomas at the operated site, and placement of very far suture bites causing broad hash marks. As Gustafson et al. pointed out, all sarcomas ideally should be managed in a specialist sarcoma center with the aid of a multidisciplinary team.
In this study, we aimed to identify the prevalence of such uP excisions in our part of the world and to compare the oncological outcomes of patients who underwent uP excisions from outside with those who underwent planned excisions within our institute.
| Materials and Methods|| |
This was a retrospective study conducted in an Indian tertiary cancer center from June 2009 to December 2015. The research protocol [Supplementary Appendix 1] was approved by the institutional review board (IRB), and the requirement for individual patient consent was waived by the IRB given the retrospective nature of the study. The study complied with the ethical guidelines as stated in the Declaration of Helsinki and the Indian Council of Medical Research clinical trial guidelines for good clinical practice. We did not receive any funding for the study. All patients with STS undergoing surgery per primum or after an initial uP surgery outside were included in the study. Recurrent tumors after oncological resection, retroperitoneal sarcomas, gastrointestinal stromal tumors, and pediatric sarcomas were excluded. Excisions were deemed 'uP' if they were performed without prior imaging and/or biopsy that resulted in marginal or intralesional excisions.
The management of each patient was discussed in a multispecialty tumor board. The tumor board included surgical oncologists, radiation oncologists, medical oncologists, radiologists, and pathologists. Patients with uP excision were evaluated with magnetic resonance imaging to look for residual disease, and computerized tomography (CT) scans of the thorax to rule out lung metastases. Histopathological review of slides/blocks was done by a dedicated sarcoma pathologist in the institution. Wherever available, review of the histopathology specimen was undertaken. The French Federation of Cancer Centers Sarcoma Group system was used for grading. In most cases, it was difficult to determine the area of margin positivity, in margin-positive resections. In addition, such cases were discussed with the primary surgeon via phone or letter correspondence to find out the exact area of margin positivity (if the surgery was planned or uP) and whether any attempt was made at achieving adequate margins.
The preoperative and postoperative images were carefully compared prior to re-do surgery. Re-wide excision of the scar with adequate margin was the standard surgery performed. If no residual disease was present on clinical examination and imaging, a 2 cm margin was given all around the scar. If residual disease was found, the lesion was re-excised with a 2–3 cm additional margin. The reconstruction was done based on the size of the tissue defect, the orientation of the previous scar, and location of the tumor.
Wound morbidity was calculated using the Clavien–Dindo grading system. The grading is based on the type of intervention used in order to negate the surgical morbidity. Grades I and II indicate minor complications where nonsurgical management is sufficient. Grade IIIA morbidity requires intervention under local anesthesia, and IIIB requires surgical intervention under general/regional anesthesia. Grade IV is life-threatening complication with single (IVA)- or multiple (IVB)-organ failure, whereas Grade V morbidity stands for mortality.
Patients with high- or intermediate-grade tumors, larger than 5 cm, and/or deep tumors were treated with adjuvant radiation therapy. The dose of adjuvant radiotherapy administered was 60 Gray (Gy) in 1.8 Gy/fraction using intensity-modulated radiation therapy or three-dimensional conformal radiation therapy techniques. Patients with large tumors and chemosensitive histology were offered additional adjuvant chemotherapy. The chemotherapy regimen used was ifosfamide (1.8 g/m2) and adriamycin (60 g/m2) along with Mesna (2-mercaptoethane sulfonate Na), administered every 3-weekly for 6 cycles. Neoadjuvant radiation was administered to patients with bulky disease and borderline operability.
All patients were followed up 3 monthly for the first 2 years, 6 monthly for the next 3 years, and yearly thereafter. At each visit, a complete physical examination was done. Imaging of the chest was done at 6-monthly intervals by chest X-ray and annual CT scan of the thorax. Additional imaging was done only if patient was symptomatic or if there was suspicion of disease recurrence. If the patient had not visited the hospital in the preceding 3 months, telephonic enquiry was made to update the last follow-up status. If this is not available, the patient was considered lost to follow-up.
The file numbers of patients were collected from the surgical registers and case records. The demographic profile, tumor characteristics, surgical details, morbidity, and oncological outcomes were documented and analyzed.
IBM SPSS Statistics (Version 20.0. Armonk, NY, USA: IBM Corp.) was used for analysis. Descriptive and inferential statistics were used for data analysis. Kaplan-Meier method, was used for calculating the disease-free survival (DFS) and overall survival (OS) and log-rank test was used for comparing survival function. Reverse Kaplan–Meier method was used to calculate the follow-up of all patients. The Chi-squared test was used to assess the presence of statistical difference in parameters such as age, presence of Grade III tumors, and administration of adjuvant radiotherapy. DFS was defined as the time period from the date of initial surgery till the development of recurrence or death due to disease, whichever was earlier. OS was defined as the time period from the date of initial surgery to death due to any cause or last follow-up. P <0.05 was considered statistically significant.
| Results|| |
A total of 69 patients were initially evaluated; 47 (68.12%) patients underwent uP excision outside. Eighteen patients who defaulted treatment after the excision and presented with recurrent disease several months or years after initial excision were excluded from further analysis. Thus, 51 patients were included in the study [Figure 1].
|Figure 1: Flowchart of patients with soft-tissue sarcoma who underwent unplanned excisions outside and were then referred to our institute and patients who underwent planned oncological excision at our institute|
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Twenty-two (43.13%) patients underwent planned excision (Group P), while 29 (56.86%) in the study group underwent uP excisions in peripheral hospitals (Group uP). The demographic profile and surgicopathological and oncological variables (including recurrences) between the two groups have been tabulated in [Table 1]. After uP excisions, 75.9% of patients had positive margins and 58.6% of patients had residual tumor at operated site.
|Table 1: Patient demographic factors, disease characteristics, treatment factors, and oncological outcome of the patients who underwent planned excision of soft.tissue sarcoma in the cancer center and those who underwent unplanned excision outside followed by rewide excision in the cancer center are shown and compared in the table|
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Patients in the uP group were younger compared to those in Group P, and this difference was statistically significant. More patients in Group P had Grade III tumors compared to group uP; however, this difference did not achieve statistical significance.
One patient from the group P received neoadjuvant radiation in view of bulky disease and this patient had a Grade 3B wound morbidity as per the Clavien–Dindo system. Four patients had undergone more than one uP excision outside. In addition, 2 patients had had three excisions outside in an attempt to achieve a negative margin. Majority of the patients (n = 40; 78.4%) underwent primary closure of the wound post excision. No patient in this study required amputation for oncological reasons.
Fifteen patients (68.19%) in the P group and 21 (87.5%) in the uP group received adjuvant radiation as planned. This difference did not achieve statistical significance (P = 0.163) and the 95% confidence interval (CI) was –45.76 to −7.38. The number of patients who did not receive adjuvant radiation and the reasons thereof are shown in [Table 2].
|Table 2: The number of patients who did not receive adjuvant radiation as planned in the groups who underwent planned excision and those who underwent unplanned excision and the reasons thereof are shown the table|
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The median follow-up for all patients was 44 months. There were seven deaths in group P and two deaths in the uP group: both patients had residual disease on final histopathology. Twelve patients were lost to follow-up. Median OS was not reached. The mean OS was 80.36 ± 10.76 months (95% CI, 59.27–101.46) in group P and 104.52 ± 5.09 months (95% CI, 94.54–114.5) in group uP (P = 0.032) [Figure 2]. The mean DFS for groups P and uP were 56.34 ± 10.01 months (95% CI, 36.73–75.95) and 60.12 ± 9.63 months (95% CI, 41.25–78.98) (P = 0.597) and median DFS were 80 ± 26.32 months (95% CI, 28.42–131.59) and 66 ± 13.09 months (95% CI, 40.33–91.67), respectively [Figure 3].
|Figure 3: Kaplan–Meier curves for disease-free survival in the two groups|
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Nine patients developed local recurrence, six in group P and three in uP. Overall, 17 patients (33.33%) developed distant recurrences, Nine in group P (40.9%) and eight in group uP (27.59%). The sites of recurrence were the lung (n = 12), bone (n = 3), lymph nodes (n = 3), liver (n = 1) and brain (n = 1). Three patients developed metastasis at more than one site mentioned above. Four patients with lung metastases underwent metastatectomy at a median period of 31 months. Three of these patients are alive without recurrence and all of them belonged to Group uP.
| Discussion|| |
We found that over a 6-year period, 47 of 69 patients with STS underwent uP excision (68%). After excluding patients who defaulted treatment, 51 patients (22-planned excisions – P, 29-uP excisions – uP) were included in our study. The patients who underwent uP excision appeared to be younger, have less Grade III tumors, and smaller tumor size compared to those who underwent planned wide excision, although none of these differences reached statistical significance. It is possible that planned excisions were generally done for larger tumors at presentation meaning the chance of having a high-grade tumor was more in this group. 22 patients (76%) had positive margins after initial excision and 17 (59%) had residual disease in the pathology specimen after repeat wide excision. The estimated OS at 5 years was significantly better for the uP group, but DFS was comparable. Incidence of distant metastasis and local recurrence was comparable, but more patients in the uP group were salvaged with metastasectomy.
The incidence of uP excision varies from 18% to 53% in various reports.,,,,, We were unable to find any Indian data regarding this. To the best of our knowledge, we report the highest incidence of uP excisions in the English literature. This shows the importance of improving awareness of STS among general practitioners and surgeons in India. As per the United Kingdom (UK) national guidelines which were formulated in the year 2000, any patient with a lump that was bigger than 5 cm, increasing in size, deep to the deep fascia or painful should be considered to be a sarcoma until proved otherwise and referred for investigation to a sarcoma unit. This guideline was sent to all the general practitioners in the UK and reissued 5-yearly. As per the recent data from the Royal Orthopaedic Hospital, Birmingham, the incidence of uP excision has come down to 10%, from 25% to 30% as in the late 90s. At the same time, we should also be wary about the other side of this argument, i.e., a large number of benign soft tissue tumors being referred to tertiary cancer centers by overcautious general practitioners and reluctant general surgeons.
Three-quarters of our patients had positive margins in the initial surgery and 59% had residual disease in the re-resection specimen. This concurs with the data from the literature where the presence of residual disease was detected in 31%–72% of those who underwent re-resection.,,,,,,,,,,, The data justify re-resection in all patients who undergo uP excision of STS.
Various studies have reported contradictory results in terms of oncological outcomes in repeat wide excision when compared with primary planned excision in STS. Lewis et al. demonstrated that patients undergoing two excisions had a better DFS than patients undergoing single excision at a tumor center. This improved survival persisted even when other factors affecting survival, such as age, grade, depth, and histology, were accounted for. This led to the belief that “Two excisions are probably better than one” and a really wide resection improves prognosis. However, later studies have shown comparable oncological outcomes between the two groups of patients.,,,
In our study, patients with uP excisions had improved OS compared to those who underwent P excision in the cancer center. The DFS was, however, similar in both groups. The average tumor size was higher in Group P, more patients in Group P had high-grade tumors and the percentage of patients who received adjuvant radiotherapy in the Group P was less, although statistical significance was not present for any of the above factors individually. However, we think that the presence of multiple adverse prognostic factors resulted in inferior oncological outcomes in Group P. More patients in the uP group had limited metastases and were salvaged with metastatectomy, and this probably accounts for better OS in these patients, despite having similar DFS.
The limitations of the study are the relatively small number of patients included, retrospective nature, and lack of information regarding functional outcomes. The events were few, and some differences did not reach statistical significance.
| Conclusions|| |
Patients who undergo uP excision require reexcision to ensure complete removal of tumor tissue and reduce the risk of local recurrence. Initial uP surgery does not compromise oncological outcome in patients with STS, provided they are subjected to reexcision and standard adjuvant treatment.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| Supplementary Appendix 1: Study Protocol|| |
| Unplanned excision in soft tissue sarcoma – The unkindest cut of all!!|| |
M. P. Nizamudheen, B. Satheesan, John J. Alapatt, Abhay K. Kattepur, Bright Singh
| Introduction|| |
Soft-tissue sarcomas (STSs) are rare tumors with an incidence of 1/100,000, and soft-tissue lump is many times more likely to be benign than malignant. This is why a soft-tissue tumor usually undergoes a excision without a proper preoperative imaging, biopsy, or planning. An unplanned (uP) excision of a STS (in majority of similar studies) is any excision which was either done without a preoperative core biopsy. It will also include all excisions with involved margins or if the status of the margins is not commented upon in the outside histopathology report. uP excisions result in positive resection margins, which translates into local recurrences to the tune of 70%–90%. The manifold problems with a uP excision are:
- The contamination of the various tissue layers around the tumor with malignant cells and all cancerous cells may not be removed in rewide excision
- Rewide excision may result in more tissue loss around the patient's limb which may result in affected function
- The need for a swift reresection may delay the adjuvant treatment which might be required
- Residual tumors in reexcised specimens have been implicated with increased clinical aggressiveness, increased distant metastasis, and increased local recurrence
- The emotional turmoil which a patient has to undergo due to a second surgery
- Therefore, ideally, all sarcomas should be managed in a specialist sarcoma center with the aid of a multidisciplinary team, and a planned wide excision of the tumor should have superior oncological outcomes to a re-wide excision.
| Literature Review|| |
- Lewis et al. demonstrated that patients undergoing reexcision after incompletely excised STS had a better prognosis than patients undergoing single excision at a tumor center
- Fiore et al. published a study which found that there is no difference in prognosis between the two groups. Since these results seem to indicate that reexcision offers patients the same or better prognosis than a single-stage planned excision even after adjusting for high-risk variables
- Almanda et al. study proved there were no differences in death, metastases, or local recurrence between the two groups after adjusting for high-risk variables. The purported survival advantages previously reported with STS reexcision served only as a proxy for tumors that have a better survival profile.
The various studies have portrayed contradictory results in terms of oncological outcomes in rewide excision when compared with primary planned excision in STS.
Our study aims to ascertain the overall survival (OS) and the disease-free survival (DFS) in the two groups of rewide excision versus primary surgery at our center. It also aims to ascertain the various factors which may influence the oncological outcomes in the two groups.
| Hypothesis|| |
The patients with STS who underwent primary surgery in Malabar Cancer Centre (MCC) have a better oncological outcome compared to those who underwent uP excision outside followed by rewide excision in MCC.
| Research Question|| |
What is the difference in oncological outcomes in patients who underwent a rewide excision after an uP surgery in a peripheral hospital, in comparison to patients who underwent a primary excision of STS of the extremity/trunk from a tertiary cancer center with expertise in sarcoma management.
The aim of the study is to compare the oncological outcomes of patients who underwent a rewide excision following uP excision in a peripheral hospital, with those who underwent a planned wide excision from a tertiary cancer center.
The main objectives are:
- To evaluate the OS and DFS in both the groups of the study
- To identify the various factors influencing the oncological outcomes in both the groups
- To estimate and compare the wound-related morbidity and 30-day mortality in both the groups.
| Materials and Methods|| |
MCC, the study site, is a 200 bedded Tertiary Cancer Centre with a referral base from the northern part of Kerala and neighboring state of Karnataka and Mahe (Puducherry).
- Study design – Retrospective study
- Study period – The patients of STS of the extremity/trunk who were treated from January 2010 to December 2016 in MCC, Kodiyeri
- Study population – Patients with STS who have been referred to MCC after an uP excision and who subsequently underwent a rewide excision and patients who have underwent a primary-planned excision from our center.
- Hospital ID numbers of the patients with STS and details of the surgery performed will be obtained from the surgical register
- The previous histopathology report from the outside center and the slide review from our center will be compared with our final histopathology report
- The data collection will be done from the case file according to the variables mentioned in the pro forma.
uP excision: Those excisions of soft-tissue tumors with adequate presurgical evaluation and those:
*Excisions without a preoperative biopsy.
*Excisions with either inadequate or involved margins or margins not commented on in outside histopathology report.
- All patients of STS of the trunk/extremity who underwent an uP excision* from elsewhere and rewide excision from our center
- Those who underwent incision biopsy outside followed by wide excision in MCC
- All patients of STS of trunk/extremity who underwent primary planned excision from our center.
- Metastatic or recurrent STSs*
- Patients who have undergone uP excision from outside and who have presented to our center after a period of 6 months shall be excluded from the study
- Retroperitoneal, bone sarcoma, and pediatric sarcomas
- Patients whose case records are incomplete and those who have a follow-up period of <6 months
- All patients who are diagnosed with radiation-associated sarcoma
- All patients with a history of any synchronous or metachronous cancers.
Data were be collected and recorded in the designed pro forma. All analyses will be conducted using IBM SPSS Statistics (Version 20.0. Armonk, NY: IBM Corp.). Data will be expressed in number, Mean, standard deviation, median, and interquartile range. Kaplan–Meier analysis will be used to assess survival in both groups. Cox regression analysis will be used to assess the influence of various factors on survival. In all the analyses, P < 0.05 will be considered statistically significant. The appropriate statistical test will be applied to attain the objectives of the study.
| Ethics Considerations|| |
- The permission from the IRB/institutional scientific committee will be obtained for the study
- The process of data collection will not pose any risk or harm to the subjects as no kind of intervention or any interference with treatment is undertaken in this study
- Data confidentiality: The names of the patients will not be entered anywhere in the study.
Dissemination of results
- The results will be published in peer-reviewed national and international journals and conferences, increasing the body of knowledge and informing the larger scientific/medical body
| Potential Impact of the Study|| |
| References (Study Protocol)|| |
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[Figure 1], [Figure 2], [Figure 3]
[Table 1], [Table 2]