scholarly journals OPTimizing Irradiation through Molecular Assessment of Lymph node (OPTIMAL): a randomized open label trial

2020 ◽  
Vol 15 (1) ◽  
Author(s):  
Manuel Algara López ◽  
Elvira Rodríguez García ◽  
Inmaculada Beato Tortajada ◽  
Francisco José Martínez Arcelus ◽  
Juan Salinas Ramos ◽  
...  
Keyword(s):  
Lymph Node ◽  
Treatment Strategy ◽  
Early Stage ◽  
Disease Free Survival ◽  
Conservative Surgery ◽  
Molecular Techniques ◽  
Nucleic Acid Amplification ◽  
Open Label ◽  
Recurrence Rates ◽  
Axillary Nodes

Abstract Background Conservative surgery followed by breast and nodal irradiation is the standard loco-regional early breast cancer (BC) treatment for patients with four or more involved lymph nodes. However, the treatment strategy when fewer nodes are involved remains unclear, especially when lymphadenectomy has not been performed. Sensitive nodal status assessment molecular techniques as the One-Step Nucleic Acid Amplification (OSNA) assay can contribute to the definition and standardization of the treatment strategy. Therefore, the OPTIMAL study aims to demonstrate the feasibility of incidental irradiation of axillary nodes in patients with early-stage BC and limited involvement of the SLN. Methods BC patients who underwent conservative surgery and whose SLN total tumour load assessed with OSNA ranged between 250–15,000 copies/µL will be eligible. Patients will be randomized to receive irradiation on the breast, tumour bed, axillary and supraclavicular lymph node areas (intentional arm) or only on the breast and tumour bed (incidental arm). All areas, including the internal mammary chain, will be contoured. The mean, median, D5% and D95% doses received in all volumes will be calculated. The primary endpoint is the non-inferiority of the incidental irradiation of axillary nodes compared to the intentional irradiation in terms of 5-year disease free survival. Secondary endpoints comprise the comparison of acute and chronic toxicity and loco-regional and distant disease recurrence rates. Discussion Standardizing the treatment and diagnosis of BC patients with few nodes affected is crucial due to the lack of consensus. Hence, the quantitative score for the metastatic burden of SLN provided by OSNA can contribute by improving the discrimination of which BC patients with limited nodal involvement can benefit from incidental radiation as an adjuvant treatment strategy. Trial registration ClinicalTrial.gov, NCT02335957; https://clinicaltrials.gov/ct2/show/NCT02335957

scholarly journals OPTimizing Irradiation through Molecular Assessment of Lymph node (OPTIMAL): a randomized open label trial.

2020 ◽  
Author(s):  
Manuel Algara ◽  
Elvira Rodríguez ◽  
Inmaculada Beato ◽  
Francisco José Martínez ◽  
Juan Salinas ◽  
...  
Keyword(s):  
Lymph Node ◽  
Treatment Strategy ◽  
Early Stage ◽  
Disease Free Survival ◽  
Conservative Surgery ◽  
Molecular Techniques ◽  
Nucleic Acid Amplification ◽  
Open Label ◽  
Recurrence Rates ◽  
Axillary Nodes

Abstract Background: Conservative surgery followed by breast and nodal irradiation is the standard loco-regional early breast cancer (BC) treatment for patients with four or more involved lymph nodes (LN). However, the treatment strategy when fewer nodes are involved remains unclear, especially when lymphadenectomy has not been performed. Sensitive nodal status assessment molecular techniques as the OSNA (One-Step Nucleic Acid Amplification) assay can contribute to the definition and standardization of the treatment strategy. Therefore, the OPTIMAL study aims to demonstrate the feasibility of incidental irradiation of axillary nodes in patients with early-stage BC and limited involvement of the SLN. Methods: BC patients who underwent conservative surgery and whose SLN total tumour load assessed with OSNA ranged between 250–15,000 copies/µL will be eligible. Patients will be randomized to receive irradiation on the breast, tumour bed, axillary and supraclavicular lymph node areas (intentional arm) or only on the breast and tumour bed (incidental arm). All areas, including the internal mammary chain, will be contoured. The mean, median, D5% and D95% doses received in all volumes will be calculated. The primary endpoint is the non-inferiority of the incidental irradiation of axillary nodes compared to the intentional irradiation in terms of 5-year disease free survival. Secondary endpoints comprise the comparison of acute and chronic toxicity and loco-regional and distant disease recurrence rates.Discussion: Standardizing the treatment and diagnosis of BC patients with few nodes affected is crucial due to the lack of consensus. Hence, the quantitative score for the metastatic burden of SLN provided by OSNA can contribute by improving the discrimination of which BC patients with limited nodal involvement can benefit from incidental radiation as an adjuvant treatment strategy. Trial registration: ClinicalTrial.gov, NCT02335957; https://clinicaltrials.gov/ct2/show/NCT02335957

scholarly journals OPTimizing Irradiation through Molecular Assessment of Lymph node (OPTIMAL): a randomized open label trial.

2020 ◽  
Author(s):  
Manuel Algara ◽  
Elvira Rodríguez ◽  
Amanda Flaquer ◽  
Inmaculada Beato ◽  
Francisco José Martínez ◽  
...  
Keyword(s):  
Lymph Node ◽  
Lymph Nodes ◽  
Treatment Strategy ◽  
Early Stage ◽  
Disease Free Survival ◽  
Conservative Surgery ◽  
Molecular Techniques ◽  
Nucleic Acid Amplification ◽  
Open Label ◽  
Axillary Nodes

Abstract BackgroundConservative surgery followed by breast and nodal irradiation is the standard loco-regional treatment for early breast cancer (BC) patients with four or more involved lymph nodes. However, the treatment strategy when fewer nodes are involved remains unclear, especially when lymphadenectomy has not been performed. Sensitive molecular techniques for nodal status assessment such as the OSNA (One-Step Nucleic Acid Amplification) assay can contribute to the definition and standardization of the treatment strategy. Therefore, the OPTIMAL study aims to demonstrate the feasibility of the incidental irradiation of axillary nodes in patients with early-stage BC and limited involvement of the SLN.MethodsBC patients with conservative surgery and a total tumour load of sentinel lymph nodes assessed with OSNA ranged between 250–15.000 copies/µL will be eligible. Patients will be randomized to receive irradiation on breast, tumour bed, axillary and supraclavicular lymph node areas (intentional arm) or only on breast and tumour bed (incidental arm). All areas, including the internal mammary chain, will be contoured. The mean, median, D5% and D95% doses received in all volumes will be calculated. The primary endpoint is the non-inferiority of incidental irradiation of axillary nodes compared with the intentional irradiation in terms of 5-year disease free survival. Secondary endpoints comprise the comparison of acute and chronic toxicity, loco-regional and distant disease recurrence rates.DiscussionStandardizing the treatment and diagnosis of BC patients with few nodes affected is crucial due to the lack of consensus on the therapeutic strategies in these patients. Hence, the quantitative score for metastatic burden of SLN provided by OSNA can contribute to improve the discrimination of BC patients with a limited nodal involvement who can benefit from incidental radiation as an adjuvant treatment strategy.Trial registrationClinicalTrial.gov, NCT02335957; https://clinicaltrials.gov/ct2/show/NCT02335957

Frühes Zervixkarzinom: Über das onkologische Outcome nach konservativer OP

2021 ◽  
pp. 1-3
Author(s):  
Moritz Hamann
Keyword(s):  
Lymph Node ◽  
Fertility Preservation ◽  
Lymph Node Dissection ◽  
Early Stage ◽  
Conservative Surgery ◽  
Pelvic Lymph Node Dissection ◽  
Pelvic Lymph Node ◽  
Node Dissection ◽  
Second Surgery ◽  
Lymph Node Assessment

<b>Objective:</b> The objective of the ConCerv Trial was to prospectively evaluate the feasibility of conservative surgery in women with early-stage, low-risk cervical cancer. <b>Methods:</b> From April 2010 to March 2019, a prospective, single-arm, multicenter study evaluated conservative surgery in participants from 16 sites in nine countries. Eligibility criteria included: (1) FIGO 2009 stage IA2-IB1 cervical carcinoma; (2) squamous cell (any grade) or adenocarcinoma (grade 1 or 2 only) histology; (3) tumor size &#x3c;2 cm; (4) no lymphovascular space invasion; (5) depth of invasion &#x3c;10 mm; (6) negative imaging for metastatic disease; and (7) negative conization margins. Cervical conization was performed to determine eligibility, with one repeat cone permitted. Eligible women desiring fertility preservation underwent a second surgery with pelvic lymph node assessment, consisting of sentinel lymph node biopsy and/or full pelvic lymph node dissection. Those not desiring fertility preservation underwent simple hysterectomy with lymph node assessment. Women who had undergone an ‘inadvertent’ simple hysterectomy with an unexpected post-operative diagnosis of cancer were also eligible if they met the above inclusion criteria and underwent a second surgery with pelvic lymph node dissection only. <b>Results:</b> 100 evaluable patients were enrolled. Median age at surgery was 38 years (range 23–67). Stage was IA2 (33%) and IB1 (67%). Surgery included conization followed by lymph node assessment in 44 women, conization followed by simple hysterectomy with lymph node assessment in 40 women, and inadvertent simple hysterectomy followed by lymph node dissection in 16 women. Positive lymph nodes were noted in 5 patients (5%). Residual disease in the post-conization hysterectomy specimen was noted in 1/40 patients-that is, an immediate failure rate of 2.5%. Median follow-up was 36.3 months (range 0.0–68.3). Three patients developed recurrent disease within 2 years of surgery-that is, a cumulative incidence of 3.5% (95% CI 0.9% to 9.0%). <b>Discussion:</b> Our prospective data show that select patients with early-stage, low-risk cervical carcinoma may be offered conservative surgery.

Standard ultrastaging compared to one-step nucleic acid amplification (OSNA) for the detection of sentinel lymph node metastases in early stage cervical cancer

2020 ◽  
Vol 30 (12) ◽  
pp. 1871-1877
Author(s):  
Angela Santoro ◽  
Giuseppe Angelico ◽  
Frediano Inzani ◽  
Damiano Arciuolo ◽  
Saveria Spadola ◽  
...  
Keyword(s):  
Lymph Node ◽  
Sentinel Lymph Node ◽  
Lymph Nodes ◽  
Early Stage ◽  
Sentinel Lymph Nodes ◽  
Nucleic Acid Amplification ◽  
Lymph Node Status ◽  
Pelvic Lymph Nodes ◽  
Lymph Node Assessment ◽  
Node Metastases

ObjectiveWe compared ultrastaging and one-step nucleic acid amplification (OSNA) examination of sentinel lymph nodes in two homogeneous patient populations diagnosed with early stage cervical cancer. The primary aim of our study was to evaluate the rate and type of sentinel lymph node metastases detected by ultrastaging and OSNA assay. Secondary aims were to define the sensitivity and the negative predictive value of sentinel lymph node biopsy assessed with OSNA and ultrastaging and to define the role of sentinel lymph node assessment in predicting non-sentinel lymph node status.MethodsConsecutive patients who underwent surgery (radical hysterectomy or trachelectomy or cervical conization) at our institution, between January 2018 and March 2020, were enrolled. All patients had a preoperative diagnosis of early-stage cervical carcinoma (International Federation of Gynecology and Obstetrics (FIGO) 2018 stages IA–IIB) and underwent sentinel lymph node assessment with ultrastaging or OSNA. Patients with advanced FIGO stages and special histology subtypes (other than squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma) or patients with sentinel lymph nodes analyzed only with hematoxylin and eosin were excluded. Clinical data were compared using the χ2 test and Fisher’s exact test. A κ coefficient was determined with respect to lymph node assessment. A p value <0.05 was considered statistically significant.ResultsA total of 116 patients were included in this retrospective analysis (53 ultrastaging, 63 OSNA). Overall, 531 and 605 lymph nodes were removed in the ultrastaging and OSNA groups, respectively, and 140 and 129 sentinel lymph nodes were analyzed in the ultrastaging and OSNA groups, respectively. 22 patients had metastatic sentinel lymph nodes: 6 (11.3%) of 53 patients in the ultrastaging group and 16 (25.4%) of 63 patients in the OSNA group. The total amount of positive SLNs was 7 (5%) of 140 in the ultrastaging group and 21 (16.3%) of 129 in the OSNA group, respectively (p=0.0047). Pelvic lymphadenectomy was performed in 26 (49.1%) of 53 patients in the ultrastaging group and in 34 (54%) of 63 patients in the OSNA group due to comorbidities. Metastatic non-sentinel lymph nodes were found in 4 patients: 2 (7.7%) of 26 patients in the ultrastaging group and 2 (5.9%) of 34 patients in the OSNA group, respectively. The total amount of positive pelvic lymph nodes was 3 (0.6%) of 531 in the ultrastaging group and 4 (0.7%) of 605 in the OSNA group (p=0.61). In the OSNA group, only 2 patients with negative sentinel lymph nodes had metastatic disease in the pelvic lymph nodes. By contrast, no patients with OSNA-positive sentinel lymph nodes had metastases in the pelvic lymph nodes. In the ultrastaging group, all patients with negative sentinel lymph nodes did not have metastatic disease in other pelvic lymph nodes.ConclusionsOSNA assessment of sentinel lymph nodes was associated with a negative predictive value of 91% but poor reliability in detecting node metastases in non-sentinel pelvic lymph nodes. Of note, the ultrastaging protocol revealed higher sensitivity and more reliability in predicting pelvic non-sentinel lymph node status.

scholarly journals One-step nucleic acid amplification (OSNA) of Sentinel Lymph Node in Early Stage Endometrial Cancer: Spanish Multicenter Study (ENDO-OSNA).

2021 ◽  
Author(s):  
M. D. Diestro ◽  
A. Berjón ◽  
I. Zapardiel ◽  
L. Yébenes ◽  
I. Ruiz ◽  
...  
Keyword(s):  
Endometrial Cancer ◽  
Lymph Node ◽  
Nucleic Acid ◽  
Sentinel Lymph Node ◽  
Early Stage ◽  
Nucleic Acid Amplification ◽  
One Step ◽  
Hematoxylin Eosin ◽  
Early Stage Endometrial Cancer ◽  
Osna Assay

The objective of this study was to evaluate the efficacy of one-step nucleic acid amplification (OSNA) for the detection of sentinel lymph node (SLN) metastasis compared to standard pathological ultrastaging in patients with early-stage endometrial cancer (EC). A total of 526 SLNs from 191 patients with EC were included in the study. 379 SLNs (147 patients) were evaluated by both methods, OSNA and standard pathological ultrastaging. The central 1-mm portion of each lymph node was subjected to semi-serial sectioning at 200-&mu;m intervals and examined by hematoxylin-eosin and immunohistochemistry with CK19; the remaining tissue was analysed by OSNA for CK19 mRNA. The OSNA assay detected metastases in 19.7% of patients (14.9% micrometastasis and 4.8% macrometastasis), whereas pathological ultrastaging detected metastasis in 8.8% of patients (3.4% micrometastasis and 5.4% macrometastasis). Using the established cut-off value for detecting SLN metastasis by OSNA in EC (250 copies/&mu;l), the sensitivity of the OSNA assay was 92%; specificity was 82%; diagnostic accuracy was 83%, and the negative predictive value was 99%. Discordant results between both methods were recorded in 20 patients (13.6%). OSNA resulted in an upstaging in 12 patients (8.2%). OSNA could aid in the identification of patients requiring adjuvant treatment at the time of diagnosis.

scholarly journals Intra-Operative Electron Radiation Therapy (IOERT) Anticipated Boost in Breast Cancer Treatment: An Italian Multicenter Experience

Cancers ◽  
2022 ◽  
Vol 14 (2) ◽  
pp. 292
Author(s):  
Antonella Ciabattoni ◽  
Fabiana Gregucci ◽  
Karen Llange ◽  
Marina Alessandro ◽  
Francesca Corazzi ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Local Control ◽  
Early Stage ◽  
Disease Free Survival ◽  
Large Data ◽  
Late Toxicity ◽  
Conservative Surgery ◽  
Early Stage Breast Cancer ◽  
Cosmetic Result ◽  
Tumor Bed

In breast cancer, the use of a boost to the tumor bed can improve local control. The aim of this research is to evaluate the safety and efficacy of the boost with intra-operative electron radiotherapy (IOERT) in patients with early-stage breast cancer undergoing conservative surgery and postoperative whole breast irradiation (WBI). The present retrospective multicenter large data were collected between January 2011 and March 2018 in 8 Italian Radiation Oncology Departments. Acute and late toxicity, objective (obj) and subjective (subj) cosmetic outcomes, in-field local control (LC), out-field LC, disease-free survival (DFS) and overall survival (OS) were evaluated. Overall, 797 patients were enrolled. IOERT-boost was performed in all patients during surgery, followed by WBI. Acute toxicity (≥G2) occurred in 179 patients (22.46%); one patient developed surgical wound infection (G3). No patients reported late toxicity ≥ G2. Obj-cosmetic result was excellent in 45%, good in 35%, fair in 20% and poor in 0% of cases. Subj-cosmetic result was excellent in 10%, good in 20%, fair in 69% and poor in 0.3% of cases. Median follow-up was 57 months (range 12–109 months). At 5 years, in-field LC was 99.2% (95% CI: 98–99.7); out-field LC 98.9% (95% CI: 97.4–99.6); DFS 96.2% (95% CI: 94.2–97.6); OS 98.6% (95% CI: 97.2–99.3). In conclusion, IOERT-boost appears to be safe, providing excellent local control for early-stage breast cancer. The safety and long-term efficacy should encourage use of this treatment, with the potential to reduce local recurrence.

Long-term oncological safety of sentinel lymph node biopsy in early-stage cervical cancer.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 6006-6006 ◽  
Author(s):  
Vincent Balaya ◽  
Benedetta Guani ◽  
Laurent Magaud ◽  
Bonsang-Kitzis Hélène ◽  
Charlotte Ngo ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Lymph Node ◽  
Sentinel Lymph Node ◽  
Early Stage ◽  
Disease Free Survival ◽  
Figo Stage ◽  
Pathologic Examination ◽  
Early Stage Cervical Cancer ◽  
Disease Specific

6006 Background: The goal of this study was to assess disease-free survival (DFS) and disease-specific survival (DSS) in patients with early-stage cervical cancer who underwent bilateral sentinel lymph node (BSLN) biopsy alone versus bilateral pelvic lymphadenectomy (BPL). Methods: An ancillary analysis of two prospective multicentric trials on SLN biopsy for cervical cancer (SENTICOL I and II) was performed. All patients with early stage cervical cancer (IA to IIB FIGO stage), negative SLN after ultrastaging and negative non-SLN after final pathologic examination were included. Risk-factors of recurrency and disease-specific deaths were determined by Cox proportional hazard models. Kaplan-Meier survival curves were compared by applying log-rank test. Results: Between January 2005 and July 2012, 259 patients met the inclusion criteria: 85 patients underwent only bilateral SLN biopsy whereas 174 patients underwent BPL. None had positive SLN at ultrastaging or positive non-SLN at final pathologic examination. Between the both groups, there was no differences in histology, final FIGO stage and type of surgical approach. In the BPL group, patients had more frequently tumor size larger than 20 mm (22.9% vs 10.7%, p = 0.02) and postoperative radiochemotherapy (10.7% vs 1.6%, p = 0.01). The median follow-up was 47 months (4-127). During the follow-up, 21 patients (8.1%) experienced reccurencies, including 4 nodal recurrences (1.9%), and 9 patients (3.5%) died of cervical cancer. The 5-year DFS and the DSS were similar between BSLN and BPL groups, 94.1% vs 97.7%, p = 0.14 and 88.2% vs 93.7%, p = 0.14 respectively. After controlling for final FIGO stage and margin status, BSLN compared to BPL was not associated with DFS (HR = 1.76, 95%CI = [0.69 – 4.53], p = 0.24) and DSS (HR = 2.5, 95%CI = [0.64 – 9.83], p = 0.19). Only final FIGO stage was independent predictor of DSS. Conclusions: SLN biopsy alone is oncologically safe in early-stage cervical cancer. Full lymphadenectomy could be omitted in case of bilateral negative SLN. Worse prognosis was associated with higher FIGO stage disease.

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