Underwent Salvage Surgery Research Articles

A multicenter retrospective study of salvage surgery for patients with residual or recurrent esophageal squamous cell carcinoma after definitive chemoradiotherapy: SURGES study.

422 Background: Salvage surgery is defined as an operation for patients with residual or recurrent tumors after definitive chemoradiotherapy (dCRT) with > 50 Gy. Although salvage surgery has been considered to improve prognosis, it is associated with a high incidence of postoperative morbidity and mortality. A previous meta-analysis by Faiz et al. reported anastomotic leakage, pulmonary disorder rates, and 90 day-mortality rates of 18.6%, 30.2%, and 8.8%, respectively. The aim of this study was to assess the efficacy and safety of salvage surgery in patients with residual or recurrent esophageal squamous cell carcinoma (ESCC) after dCRT and to explore the risk factors for postoperative complications and poor prognosis. Methods: This multi-institutional retrospective study enrolled patients treated with salvage surgery after dCRT between January 2017 and December 2021. The preoperative backgrounds of the patients were analyzed to assess their impact on survival or toxicity. Results: In total, 148 patients (59 with recurrent disease and 89 with residual disease) underwent salvage surgery at 10 leading hospitals in Japan. Post-dCRT ycT stages were T0/T1/T2/T3/T4: 12/25/30/78/3, and ycN stages were N0/N1/N2: 87/53/8. Among 136 patients who underwent esophagectomy, 108 underwent minimally invasive surgery and 28 underwent open surgery. Twelve patients had metastatic lymph nodes without primary disease. Severe postoperative complications (≧Clavien-Dindo Grade III) occurred in 39 (26.3%) patients and overall postoperative complications (≧Grade II) rate was 46.6%, including 19 (12.8%) anastomotic leakage and 25 (16.9%) pneumonia. Thirty- and 90-day mortality rates were observed in 0 and 5 (3.3%) patients, respectively. Multivariate logistic regression analysis showed that a total radiation dose ≥60 Gy (odds ratio [OR] 2.65, 95% confidence interval [CI] 1.07-6.55) and residual disease (OR 3.04, 95%CI 1.32-7.00) were associated with severe postoperative complications. The 3-year overall survival (OS) and progression-free survival (PFS) rates were 48.9% and 40.0%, respectively (median follow-up time: 42.1 months). Multivariate analysis revealed that patients with a long interval between dCRT and salvage surgery (≥180 days) had significantly longer OS (hazard ratio [HR] 0.60, 95%CI 0.38-0.95, p=0.032), and ycN0 was associated with longer PFS (HR 0.56, 95%CI 0.36-0.87, p = 0.011). The total radiation dose was not an independent prognostic factor for either OS or PFS. Conclusions: Salvage surgery is safe and provides substantial long-term outcomes. In cases with a total radiation dose of ≥60 Gy and residual disease, special caution is required because of the higher incidence of postoperative morbidity. A longer interval between dCRT and salvage surgery and ycN0 were prognostic factors.

Tremelimumab and durvalumab as neoadjuvant or non-operative management strategy of patients with microsatellite instability-high resectable gastric or gastroesophageal junction adenocarcinoma: the INFINITY study by GONO

BackgroundIn resectable gastric/gastroesophageal junction adenocarcinoma (GAC/GEJAC), microsatellite instability (MSI-H) confers improved survival, but limited benefit from chemotherapy. Immunotherapy may eliminate the need of chemotherapy or surgery. Patients and methodsINFINITY is a multicentre, multicohort phase II trial (NCT04817826) investigating in Cohort 1 the activity and safety of tremelimumab+durvalumab (T300/D) as neoadjuvant treatment for dMMR/MSI-H, resectable GAC/GEJAC. Primary endpoint was pathologic complete response (pCR) rate; Secondary endpoints: progression-free survival (PFS), overall survival (OS), quality of life (QoL), and translational analyses. In Cohort 2, the activity and safety of T300/D was explored as definitive treatment in patients achieving clinical complete response (cCR). Primary endpoint was 2-year cCR rate, Secondary endpoints: PFS, OS, QoL, gastrectomy-free survival (GFS) and translational analyses. ResultsIn Cohort 1, 18 patients were recruited and 15 evaluable. pCR and major-complete pathological response were 60% and 80%. Since pCR rate in T4 tumors was 17%, this subgroup of patients was excluded from enrollment in Cohort 2. At 28.1 months median follow-up, 24-month GC-specific PFS and OS rates were 85% and 92%. In Cohort 2, 18 patients were enrolled and 17 evaluable, 13 had cCR and started non-operative management (NOM). At 11.5 months median follow up, 1 patient had local regrowth and underwent salvage surgery, 12-month GFS was 64.2%. ConclusionsThe INFINITY study provided promising activity results of a chemo-free T300/D combination regimen as pre-operative treatment in dMMR/MSI GAC/GEJAC and the first available feasibility results of a NOM strategy in this disease setting, worth of further validation in larger cohorts.

Watch-and-Wait Approach Following Neoadjuvant Chemo-Radiotherapy for Locally Advanced Rectal Cancer: A Retrospective Single-Center Cohort Study.

The watch-and-wait (WW) strategy in patients after complete clinical response (cCR) following chemoradiotherapy for locally advanced rectal cancer (LARC) offers the option of organ preservation. The aim of this study was to assess the oncological outcomes of WW patients treated and followed up in a German referral cancer center. In this retrospective study, we analyzed the clinical records of consecutive patients with LARC who underwent neoadjuvant radiotherapy/chemoradiotherapy at our institution between January 2020 and December 2023 and received non-operative management after cCR. A total of 30 patients undergoing WW for LARC were included. After a median follow-up of 17 months (SD = 10 months), local regrowth occurred in four patients (4/30, 13.3%), and one patient (1/30, 3.3%) developed distant metastasis. No predictor for tumor regrowth could be identified based on radiological findings at diagnosis, including cT4 and/or cN2, involvement of the mesorectal fascia, extramural vascular invasion or infiltration of the anal sphincter/levator. All patients with local regrowth were successfully surgically treated (R0 resection). Nonoperative management for patients with cCR after neoadjuvant therapy for LARC proved to be safe. R0 resection was successfully achieved in all patients who underwent salvage surgery.

OGC SO43 - Management of oesophageal adenocarcinoma in the Covid-19 Pandemic – What have we learnt?

Abstract Background The management of oesophageal adenocarcinoma in the UK has been standardised to neoadjuvant chemotherapy followed by surgery. However, during the early phase of the Covid-19 pandemic, oesophagectomy was considered to be too high risk, and alternative treatment options were explored . In our unit, patients were offered definitive chemoradiotherapy with a view to performing salvage oesophagectomy if there was residual disease or disease recurrence. Method We retrospectively screened all patients referred to the UGI MDT between March 2020 to February 2021. Patients included were those with first diagnosis of oesophageal carcinoma, on the curative pathway, planned neoadjuvant FLOT chemotherapy and oesophagectomy then converted to definitive CRT (dCRT). Data collected were patient demographics, cancer staging and cancer outcomes including progression to salvage surgery, disease free survival and overall survival at 1 year and 3 years post treatment. Results Ten patients with distal or junctional adenocarcinoma were included. Median age at diagnosis was 70.5 years. Five patients had T3 or T4 disease. All patients had N0 disease. After one year, one patient had undergone salvage surgery for residual disease and two for recurrent disease. One other patient was unfit for surgery and not offered salvage surgery. At three years, only two patients had no disease recurrence. Nine of 10 patients were alive at one year and seven alive at three years. Conclusion The Covid-19 pandemic was an unusual event in our most recent history that influenced the way we managed patients with oesophageal adenocarcinoma. Little data exists as to what alternative treatments were effective. Our limited data indicates that dCRT may be used as an alternative to surgery in a subgroup of patients – although disease recurrence was common, 3-year survival was high (70%). Our data appears to be comparable to 3-year survival in our own unit and that reported in NOCGA 2024 (63%). Nevertheless, these numbers are small and thus require further study.

Does the initial treatment of primary tumor impact prognosis after recurrence in locally advanced rectal cancer? Results from a retrospective cohort analysis

IntroductionThe role of neoadjuvant therapy (NAT) in the treatment of locally advanced rectal cancer (LARC) has been well proven, but its impact on patients who relapse remains unknown. This study aims to elucidate the influence of initial treatment and MRI-defined risk factors on postrecurrent survival in patients with LARC recurrence.Patients and methodsLARC patients who underwent radical surgery and subsequently developed recurrence were retrospectively identified. Patients were stratified on the basis of MRI-defined local risk assessment and the initial treatment modality for the primary tumor (NAT or primary surgery). The patients were classified into four groups: high-risk LARC with NAT (HiN), high-risk LARC with primary surgery (HiS), low-risk LARC with NAT (LoN), and low-risk LARC with primary surgery (LoS). The primary endpoint was survival after recurrence.ResultsA total of 381 patients who experienced relapse were identified from among 2329 LARC patients. Salvage surgery was performed on 33.1% of these patients. Patients who experienced single-site recurrence or who underwent salvage surgery exhibited significantly prolonged survival times after recurrence (P < 0.001). Patients in the HiS group had poorer survival after recurrence than those in the other three groups (P = 0.034). This subset of patients, characterized by receiving less adjuvant treatment after primary surgery, had a shorter recurrence interval than those in the other groups (P = 0.001).ConclusionsOur findings reaffirm the prognostic significance of salvage surgery in patients from a LARC cohort who experienced relapse. Moreover, MRI-defined high-risk LARC patients who received upfront surgery without NAT had shorter intervals of recurrence and poorer survival outcomes after recurrence. Our results highlight the critical role of NAT in improving patient survival after recurrence.Trial registrationSupplementary registration was carried out at clinicaltrials.gov (Registration number: NCT06314737) on March 14, 2024. The study was retrospectively registered.

Survival impact of pathologic features after salvage lung resection following definitive chemoradiotherapy or systemic therapy for initially unresectable lung cancer.

Salvage surgery for primary lung cancer is expected to become increasingly common. This study aimed to clarify the survival impact of pathologic characteristics after salvage surgery. Consecutive patients who underwent salvage surgery following definitive chemoradiotherapy or systemic therapy for initially unresectable lung cancer from 2010 to 2020 were enrolled in this study. The tumor slides were reviewed to determine the size of the tumor bed and the proportions of viable tumor, necrosis, and stroma. A total of 23 patients were evaluated, and 18 had clinical stage IIIB-IV disease. Six received chemoradiotherapy and 17 received systemic therapy alone. A major pathologic response (MPR, ≤ 10% of viable tumor) was observed in 6 patients, and 4 patients achieved a pathological complete response. The 3-year overall and recurrence-free survival rates (OS and RFS) were 78.6% and 59.2%, respectively. There was no significant difference in OS between patients with and without MPR, and even non-MPR patients achieved a favorable 3-year OS of 70.2%. Meanwhile, patients with high (≥ 30%) stroma showed significantly better OS than those with low (< 30%) stroma (3-year OS: 100% vs. 23.3%, p < 0.001). This study showed that the proportion of stroma can be useful for predicting long-term survival after salvage surgery. Further large-scale studies are warranted to confirm the current findings.

EP16 - Local Excision of Rectal Cancer by Transanal Endoscopic Microsurgery (TEM) – Review of outcomes and completeness of surveillance

Abstract Aim To review outcomes and completeness of follow-up for patients undergoing TEM for rectal cancer. Method Retrospective review of outcomes of all TEM cancer operations performed by a single surgeon. Where completion surgery was not indicated, adherence to local surveillance protocol was assessed. Results 20 Patients underwent TEM for cancer from January 2014-March 2022. 55.0% (n=11) Had submucosal excision and 45.0% (n=9) full-thickness excision. 35.0% (n=7) Went on to have completion surgery, 40.0%(n=8) had surveillance only, 10.0% (n=2) received adjuvant treatment then underwent surveillance and 15.0% (n=3) declined further treatment/follow-up or were unfit. Histology was T1 in 75.0%(n=15), T2 in 20.0% (n=4) and T3 in 5.0% (n=1). Of T1 cancers 40.0% (n=6) received completion surgery, 46.7% (n=7) surveillance only and 13.3% (n=2) declined further treatment or were too unwell. Of T2 cancers 25.0% (n=1) received completion surgery, 50.0% (n=2) were considered high risk for surgery and underwent adjuvant treatment then surveillance and 25.0% (n=1) surveillance only. The patient with T3 cancer declined anything further. Overall recurrence during TEM surveillance was 30.0% (n=3). For T1 and T2 recurrence was 14.3% (n=1) and 66.7% (n=2) respectively. Two patients underwent salvage surgery, and one underwent palliative chemotherapy. Of 10 patients in surveillance after TEM, 80.0% (n=8) have currently received up to date follow-up 20.0% (n=2) have not, due to patient choice. Conclusion All patients undergoing surveillance have been offered time appropriate follow-up tests. In this sample all patients received timely and appropriate treatment.

Characteristics and outcomes of salvage surgery after immune checkpoint inhibitor therapy for initially unresectable non-small cell lung cancer.

Immune checkpoint inhibitors (ICIs) improved the long-term survival outcomes in patients with advanced non-small cell lung cancer (NSCLC), whereas the role of salvage surgery after ICIs was unknown. The object of this study was to investigate characteristics and outcomes of patients who underwent salvage surgery after ICIs. Retrospective chart review was performed on the basis of our multi-institutional database in search of consecutive patients who underwent salvage surgery after ICIs for initially unresectable NSCLC between 2016 and 2022. Patient characteristics, intraoperative findings, perioperative outcomes, histopathological findings, progression-free survival (PFS), and overall survival (OS) were investigated. Fifteen patients with a median age of 71 years were included in the study. The surgical approach was open thoracotomy in 5 and robotic or thoracoscopic surgery in 10 patients. Resection was performed for primary lesions in 8 and metastatic lesions in 7 patients. Postoperative complication was noted in 1 patient with grade 1 phrenic nerve palsy. The median PFS was 47.9 months, and the median OS was not reached. Three-year PFS was 0% in those with metastatic lesions and 87.5% in those with primary lesions (P=0.12). Salvage surgery after ICIs may be associated with low perioperative morbidity and acceptable long-term outcomes in selected patients. Salvage resection of primary lesions may be associated with more favorable PFS than of metastatic lesions.

Long-term Outcomes of Salvage Surgery Versus Induction Therapy Followed by Surgical Resection for Advanced NSCLC: A Propensity Score-matched Analysis.

The outcomes of lung cancer treatment have improved over time. However, in contrast to other treatments, the clinical outcomes of salvage surgery are seldom reported because the follow-up periods after salvage surgery are short. We conducted a comprehensive study involving consecutive patients who underwent salvage surgery at two different institutions. Our analysis encompassed the exploration of clinicopathological features, perioperative variables, and surgical outcomes. Additionally, we employed propensity score matching to compare the long-term survival of patients with non-small cell lung cancer (NSCLC) who underwent salvage surgery with those who received induction chemoradiotherapy prior to surgery. Twenty-five patients underwent salvage procedures, while 113 patients received induction chemotherapy followed by surgery during the same study period. When assessing the overall survival (OS) from the registration date to the initial treatment date, the five-year OS rates were 73.8% in the induction group and 70.5% in the salvage surgery group (p=0.674). No significant differences were identified between the two groups in a cohort of 48 patients with NSCLC who were matched using propensity scores. In patients who underwent salvage surgery, reasonable long-term survival was achieved with outcomes comparable to those of induction chemotherapy followed by surgical resection.

Reirradiation after osteocutaneous free flap reconstruction for locally recurrent head and neck cancer

PurposeRecurrent head and neck cancer poses difficult management. Even after salvage surgery, many patients are considered high-risk for further recurrence and benefit from reirradiation, despite the sequelae such as chronic wounds, tissue necrosis, osteoradionecrosis and vascular damage associated with re-irradiation. Free flaps not only enable the reconstruction following salvage surgery, but there has been limited studies suggesting that free flap reconstruction may reduce the amount of reirradiation complications. However, there are no studies to date specifically examining the effects of osteocutaneous free flap reconstruction upon reirradiation outcomes. Materials and methodsIn this retrospective study, patients with recurrent head and neck cancer that had a history of prior head and neck radiation who underwent salvage surgery with osteocutaneous free flaps followed by reirradiation were identified. Descriptive statistics were performed to assess outcomes. ResultsFive patients met criteria. Complications included chronic wound infection in one patient, fistula in one patient, plate exposure in two patients and plate removal in one patient. No patients had osteoradionecrosis or carotid rupture after reirradiation. There was an association between complications and further local disease recurrence. All patients were tube feed dependent at their most recent follow-up and two patients were tracheostomy dependent 12 months post-irradiation. Two patients had disease recurrence. Median overall survival was 16 months after reirradiation. ConclusionsOsteocutaneous free flap surgery with reirradiation may result in high rates of complications and low functional status with an equivocal improvement in survival. Larger studies are needed to substantiate these findings and assess the risk-benefit analysis.

Salvage surgery following tyrosine kinase inhibitor treatment for advanced non-small cell lung cancer

BackgroundNo standard therapy for non-small lung cancer patients that have acquired resistance to tyrosine kinase inhibitor (TKI) therapy has been established. Some can be effectively treated by salvage surgery, though indications for that procedure remain unclear. Reported here is the clinical course of a patient who experienced early post-operative distant metastases.Case presentationA 48-year-old woman without symptoms was referred to another hospital for abnormal chest radiography findings and diagnosed with adenocarcinoma of the left lower lobe (cT2aN3M1b, stage IVB; TNM staging 7th edition). Gene mutation analysis revealed positive for epidermal growth factor receptor exon 19 deletion. Afatinib treatment was started, resulting in partial response, though regrowth of the main tumor was noted 1.5 years later. Bronchoscopic re-biopsy findings revealed a T790M point mutation and afatinib was switched to osimertinib. At 1.5 years following the start of osimertinib administration, the primary tumor was found to have regrown again and stereotactic radiation therapy was administered. Findings at 3.5 years after osimertinib administration indicated that all lymph nodes and distant metastases, excluding the primary tumor, were well controlled, and the patient was referred to our hospital for salvage surgery. Osimertinib was discontinued, and a left lower lobectomy with a left lingular segmentectomy and pleural biopsy were performed. The patient was discharged following an uneventful postoperative course. Three days after discharge, glossodynia developed and examination findings revealed tongue metastasis. The symptoms improved following re-administration of osimertinib, though right adrenal gland metastasis appeared 8 months after surgery. Radiation therapy was performed for tongue and right adrenal gland metastases, and the patient was alive 1 year after salvage surgery without out-of-control lesion appearing after the radiation therapy under the administration of osimertinib.ConclusionThe present patient experienced multiple instances of systemic recurrence after undergoing salvage surgery. Experience with this case indicates that systemic therapy is essential for patients with distant metastatic lung cancer even following salvage surgery for the primary tumor.

Survival in cervical cancer IIb-IVA subjected to postchemo-radiotherapy surgery in Ecuador.

e17517 Background: Cervical cancer (CC) is one of the leading causes of cancer death in the world. The objective of the present study is to determine the overall survival (OS), survival by age group, and histological type in patients with locally advanced CC undergoing salvage surgery after chemo-radiotherapy (CTx-RTx). Methods: A retrospective observational analytical study was carried out on patients with locally advanced CC with stages IIB-IVA who received CTx-RTx treatment from January 2010 to December 2014 with follow-up until August 2023 in SOLCA-Guayaquil. The SPSSv29 statistical program was used to analyze survival curves with the Kaplan-Meier estimator and Log-Rank test. Results: Of a total of 1909 patients, 1581 were excluded because they did not meet eligibility criteria. 328 received CTx-RTx, and 23 underwent rescue surgery. The average survival result is 107 months (m). In survival by histological type, 11 patients presented squamous cell carcinoma (SCC) and 12 adenocarcinoma (AC), with the mean survival for SCC 111 months and for AC 94 months, however in the Log-Rank statistical test (p: 0.672) was not significant, which is why it is estimated that survival is similar in the two histological types (graph 2). In the calculation of survival by age in m (every ten years), in the first group of 30-39 years, it is 98.1 m, 40-49 years 118.8 m, 50-59 years 98.6 m, 60 or more years, it is 56 m; however, in the Log-Rank statistical test (p = 0.317), it is not significant by age group. Conclusions: Of the 23 patients with a mean age of 48 years and a follow-up of 168 months, 13 (56%) are alive. Regarding survival by histological type and age group, there was no significant difference in survival with these results. [Table: see text]

Intra-treatment hypoxia directed major radiation de-escalation as definitive treatment for human papillomavirus-related oropharyngeal cancer.

6007 Background: We previously reported that surgery to the primary site with hypoxia-directed de-escalated radiation to the neck for human papillomavirus associated oropharyngeal carcinoma (HPV+ OPC) can lead to excellent oncologic outcomes. We now report the results of a successor multi-center phase II trial of hypoxia-directed de-escalated chemoradiotherapy without surgery for HPV+OPC. Methods: HPV+ OPC (T0-2/N1-N2c/AJCC 7th) patients were eligible for enrollment. Tumors without evidence of hypoxia on 18F-FMISO (fluoromisonidazole) PET received de-escalated chemoradiation to 30Gy while those with hypoxia received chemoradiation to 70Gy. The primary objective was achieving a 2-year locoregional control (LRC) of 95% (failure was locoregional recurrence where surgical salvage was unfeasible) with a 7% non-inferiority margin. We enrolled a total of 158 subjects upfront to account for a 5% loss due to death (of reasons other than cancer) or follow-up. Secondary objectives were local failure (LF), regional failure (RF), distant metastasis (DM), overall survival (OS), toxicities, and patient-reported MD Anderson Dysphagia Inventory (MDADI) scores. LF, RF, and DM were estimated using the Cumulative Incidence Function, and OS was estimated using the Kaplan-Meier method. Results were reported up to 1/31/2024. Results: From 4/28/20-4/17/23, 158 HPV+ OPC patients were enrolled where150 patients were eligible for analyses. Patient characteristics: Tonsil (43%); Base of Tongue (47%); unknown primary (10%); &gt;/=10 pack years (22%); T0 (9%), T1 (44%), T2 (47%); N1 (14%), N2a (11%), N2b (59%), N2c (16%). 111 (74%) received 30Gy; 95% cisplatin. With 24 months (8-43) of median follow-up, the 2-year LF, RF, DM rates were 4.2%, 6.9%, 2.0%, respectively. The 2-year overall survival probability was 99%. Only 2 patients could not undergo salvage surgery [one 30Gy (second recurrence); one 70Gy (M1)], both received systemic therapy with durable response. Acute grade 3-4 toxicities were 32% (67% neutropenia). Mean MDADI scores: 92.93 (baseline); 68.24 (3 weeks), 91.45 (4 months) after chemoradiation. Conclusions: These early data indicate that major de-escalation to 30Gy based on hypoxia status achieved significant toxicity reduction without compromise in survival for HPV+ OPC treated with chemoradiation without surgery. Clinical trial information: NCT03323463 .

Neoadjuvant HPV16-specific arenavirus-based immunotherapy HB-200 plus chemotherapy followed by response-stratified de-intensification in HPV16+ oropharyngeal cancer: TARGET-HPV.

6017 Background: The role of immunotherapy in curative viral-mediated oropharyngeal cancer (OPC) remains undefined. Human papillomavirus (HPV) 16 positive (+) OPC constitutively expresses viral epitopes that drive antigen-specific anti-tumor immunity, supporting rationale for evaluating neoadjuvant HPV16 directed therapeutics in non-metastatic OPC. HB-200 is an arenavirus-based vector therapy derived from LCMV (HB-201) and Pichinde virus (HB-202) each expressing a non-oncogenic HPV16 E7E6 fusion protein to induce HPV16 specific CD8+ T-cell responses. Building on our OPTIMA II results demonstrating that neoadjuvant chemotherapy/nivolumab led to deep responses in 71% of patients who went on to receive reduced radiation (RT), we hypothesized that adding HB-200 to chemotherapy to drive HPV16-specific anti-tumor immunity would be safe and effective to further deepen responses and facilitate more de-escalation. Methods: In this Phase 1 dose escalation investigator-initiated study, patients with non-metastatic HPV16+ OPC were treated with escalating doses of HB-201 single vector (Arm A) or HB-202/201 alternating vector (Arm B) x3 with neoadjuvant carboplatin AUC5 on day 1 and paclitaxel 100mg/m2 on days 1/8/15 of a 21-day cycle for 3 cycles. Deep responders (≥50% tumor shrinkage) received transoral robotic surgery (TORS) alone or RT to 50Gy +/- cisplatin, while non-responders (&lt;50% shrinkage) received 50 or 70Gy of RT with cisplatin. Primary objective was safety/tolerability and recommended phase 2 dose of HB-200 with chemotherapy. Additional objectives included deep response rate, circulating tumor (ct) HPV-DNA dynamics, and HPV16-specific T-cell response. Results: Twenty-one patients with HPV16+ OPC were enrolled and treated (Arm A, n=9, 43%; Arm B, n=12, 57%). Median age 57, 91% male, 75% base of tongue, 52% non-smokers, and 33% stage II/III (AJCC 8th edition). ≥Grade 3 treatment-emergent adverse events (AEs) occurred in 13 (62%) of patients overall and 3 (14%) non-hematologic during neoadjuvant. There were no Grade 4 AEs reported. All patients completed neoadjuvant HB-200/chemotherapy and response-stratified locoregional treatment. Deep responses following HB-200/chemotherapy were observed in 17/21 (81%) of patients, and in 14/15 (93%) treated on higher dose levels 1 or 2 ( p=0.05). All three patients who underwent TORS had no viable tumor at time of surgery. Two patients (9%) had persistent disease following CRT and underwent salvage surgery with no evidence of disease at last follow-up. ctHPV-DNA and HPV16-specific T-cell response data will be presented at the meeting. Conclusions: Neoadjuvant HB-200/chemotherapy is safe and feasible with early efficacy signal in this setting warranting further study. Enrollment to the subsequent randomized phase II part is ongoing (NCT05108870). Clinical trial information: NCT05108870 .

A phase II trial of reirradiation combined with pembrolizumab in patients with locoregional inoperable recurrence or second primary squamous cell carcinoma of the head and neck (HNSCC).

6049 Background: Better outcomes are needed for patients (pts) with locoregional inoperable recurrence or second primary HNSCC after prior radiation therapy. Methods: We conducted a phase II single arm trial of hyperfractionated reirradiation (ReRT, 1.2 Gy BID for total 60Gy to gross disease + margin without elective nodal radiation) plus pembrolizumab (P) (200mg q3 weeks starting day 1 of ReRT). P was continued until confirmed CR or if no CR, until disease progression or up to 24 months. All pts underwent a 3 month post ReRT PET/CT and subsequently CT neck/chest after every 3rd cycle of P. Pts included had: Locoregional recurrence or second primary HNSCC (excluding skin or salivary), were unresectable or not willing to undergo resection, one RT course completed at least 6 months prior, with &gt;50% tumor volume treated at doses &gt;45Gy, ECOG PS 0-1, a target lesion by RECIST, no distant metastasis, and no prior anti-PD-1/PD-L1. Primary endpoint was PFS, and the hypothesis was that the median PFS would increase from the historical control of 8 months (mo) to 12 mo, α=0.05, power 78%, n=48. Secondary endpoints: ORR by RECIST, OS, toxicity, QOL (EORTC). The Kaplan-Meier method was used to estimate PFS and OS. Results: In the 48 evaluable pts, median age was 65.5 (range 44-79), 62.5% male. Primary site: hypopharynx (8.3%), larynx (6.3%), nasopharynx (10.4%), oral cavity (43.7%), oropharynx (31.3%, one HPV+ pt). Median doses of P was 8, median RT dose was 60 Gy and 20.8% received proton RT, remainder IMRT. Median follow up was 49.1 months. The median PFS was 8.3 mo (95%CI 5.5-10.3), and median OS was 13.8 mo (95% CI 9.5-21.8). 1 and 3-year PFS were 28.9% and 22.3% respectively, and for OS 54.2% and 25.7%, respectively. 42 pts were evaluable for response and the ORR was 54.8% (33.3% CR, 21.4%PR), 21.4% SD, 23.8% PD. In an exploratory analysis, the median PFS was 13.8 mo (95% CI 9.1-NR) and the median OS was 57.8 mo (19.6-NR) in patients that had a response (CR/PR, n=23), with a 1 and 3-year PFS of 51.8% and 42.4%, respectively, and for OS 78.3% and 51.7%, respectively. All patients had at least one treatment related AE (TRAE), defined as possibly, probable, or definitely related to treatment. 39% of pts had a G3 TRAE and the most common ones were: aspiration, dehydration, anemia, dysphagia, dyspnea. 4 patients had a G5 TRAE (found down deceased, epistaxis, aspiration pneumonia, iRAE pneumonitis). Conclusions: Our prospective trial uniquely evaluated ReRT plus pembrolizumab in patients with locoregional recurrence/second primary HNSCC that did not undergo salvage surgery. The primary endpoint of PFS was not improved compared to historical control. PD-L1 biomarker analysis is ongoing and will be reported subsequently. Clinical trial information: NCT02289209 .

Management Approaches in WHO Grade III Meningioma: A National Oncology Trainees' Collaborative for Healthcare Research (NOTCH) UK Multi-Centre Retrospective Study

AimsWHO Grade 3 (G3) meningiomas are rare tumours with limited data to guide management. This retrospective study documents UK management approaches across 14 centres over 11 years. Materials and methodsPatients with WHO G3 meningioma between 01/01/2008 and 31/12/2018 were identified. Data were collected on demographics, management strategy, adjuvant radiotherapy, approach in recurrence setting and survival. Results84 patients were identified. 21.4% transformed from lower-grade disease. 96.4% underwent primary surgical resection, with 20.8% having evidence of residual disease on their post-op MRI. 59.3% of patients underwent adjuvant radiotherapy (RT) following surgical resection.Overall median PFS and OS were 12.6 months and 28.2 months, respectively. Median OS in the group who underwent complete surgical resection was 34.9 months, compared to 27.5 months for those who had incomplete resection (HR 0.58, 95% CI 0.27–1.23, p = 0.15). Median OS was 33.1 months for those who underwent adjuvant RT and 14.0 months for those who did not (HR 0.48, 95% CI 0.27–0.84, p = 0.004). Median adjuvant RT dose delivered was 60Gy (range 12Gy–60Gy), 45.8% of adjuvant RT was delivered using IMRT.At disease relapse, 31% underwent salvage surgery and 29.3% underwent salvage RT. Of those treated with salvage RT, 64.7% were re-treats and all were treated with hypofractionated RT. ConclusionSurgery continues to be the preferred primary management strategy. Post-operative MRI within 48 hours is indicated to assess presence of residual disease and guide further surgical options. Adjuvant radiotherapy plays an important part of the management paradigm in these patients with the data supporting an attached survival advantage. Further surgery and re-irradiation is an option in the disease recurrence setting with radiosurgery frequently utilised in this context.

Patient Preference for Surgical Methods for Ipsilateral Breast Tumor Recurrence.

Mastectomy has been the standard surgical treatment for ipsilateral breast tumor recurrence (IBTR). Recently, there has been growing interest in repeat breast-conserving surgery (rBCS) for IBTR among breast surgeons; however, there is currently little information regarding patient preferences for surgical procedure for IBTR. The purpose of this study was to evaluate preference for surgical procedure (mastectomy vs. rBCS) among breast cancer patients who had undergone salvage surgery for IBTR. Overall, 100 breast cancer patients who had undergone salvage surgery for IBTR were asked about their preferred surgical methods for IBTR and the reason. The association of patient preference and the reasons related to various clinical and pathological factors were assessed. Of the 100 respondents, only 11 patients (11%) preferred rBCS. Patients who had undergone rBCS and radiotherapy for IBTR were significantly more likely to prefer to undergo rBCS than other groups (p = 0.030). The most frequent reason for choosing rBCS was the patient's desire to minimize breast deformity and surgical wounds. Our study revealed that there is a low rate of patients who opt to undergo rBCS among patients who had undergone salvage surgery for IBTR. Discrepancies in perceptions regarding the surgical procedure for IBTR between patients and their surgeons may exist.

Survival and clinical outcomes of salvage surgery in recurrent oral cavity cancer: a single institutional experience

Background: Oral cavity is the most common site of head and neck squamous cell carcinoma in India with more than 70% presenting in locally advanced stage. Recurrence in all stages of OCSCC occurs in up to 50% of patients, with most failures being local and/or regional relapses. The present study was done to analyze clinical outcomes of patients undergoing salvage surgery (SS) following recurrent OCSCC. Methods: A retrospective analysis of prospectively collected data of 82 patients with recurrent OCSCC was done in the department of head and neck surgery. Results: At the end of 1 year post SS for OCSCC 62 out of 82 (75.6%) patients were alive without disease. At the end of 2 year after SS 22 out of 45 patients were alive of which 21 were alive without disease and 1 was alive with disease (48.8%). At the end of 3 years, 10 out of 25 of which 9 were alive without disease and 1 patient was alive with disease (40%). Median disease-free survival (DFS) post SS was 13.50 months (0-47 months). DFS and overall survival (OS) post SS showed significantly better results in patients treated with surgery along with RT as primary treatment, patients with late recurrence, patients with early recurrent T stage, patients with free margins at SS and in patients who received adjuvant radiation therapy post SS. Conclusions: Salvage Surgery is one of the best treatment options for recurrent OCSCC with acceptable survival rates.

Salvage extended surgery after immune-checkpoint inhibitor treatment for advanced non-small cell lung cancer.

We evaluated the surgical outcomes of salvage extended surgery after definitive medical treatment with an immune-checkpoint inhibitor (ICI) for locally advanced or unresectable non-small-cell lung cancer (NSCLC). The subjects of this single-center retrospective analysis were 14 patients who underwent salvage surgery after ICI treatment between May, 2017 and April, 2023 at our institute. We reviewed the comprehensive surgical outcomes, including operative procedures, intraoperative findings, and postoperative morbidities. Overall survival (OS) was calculated using a Kaplan-Meier estimation. The initial clinical stage before medical treatment (c-stage) was stage III in eight patients, stage IV in five patients, and one patient had postoperative lung cancer recurrence. The indications for surgery were as follows: local control for relapse or residual tumor in ten patients and discontinuation of systemic therapy because of treatment-related complications in four patients. The surgical modes were segmentectomy (n = 1), lobectomy (n = 4), bilobectomy (n = 3), pneumonectomy (n = 6), and bronchoplasty (n = 7). Grade 3 or higher postoperative morbidities were observed in six patients, including only one case of 90-day mortality. Our series demonstrated that the surgical outcome of salvage extended surgery after ICI therapy may be positive with careful selection of the procedure and indication.

Outcomes and pathologic response of primary lung cancer treated with tyrosine kinase inhibitor/immune checkpoint inhibitor before salvage surgery.

Advances in primary lung cancer drug therapy have extended patients' survival, including patients with stage IV disease. This study assessed the safety and effectiveness of salvage surgery following tyrosine kinase inhibitor (TKI) or immune checkpoint inhibitor (ICI) therapy in primary lung cancer. A retrospective chart review was conducted of 2050 primary lung cancer surgeries performed at our institution between 2012 and 2022. The study included patients who underwent salvage surgery for unresectable lesions that became resectable or localized residual lesions after treatment. We investigated patients' clinicopathological characteristics, therapeutic responses, and survival outcomes. We identified eight cases of salvage surgery after TKI treatment and eight cases after ICI treatment. Five patients experienced early recurrence after surgery; however, the long-term outcome in the post-TKI group was favorable, with a median overall survival (OS) of 66 (range: 28-80) months. Postoperative recurrence was confined to local lymph node recurrence in one patient in the post-ICI group. Despite the relatively short observation period, the long-term prognosis remained promising, with a median OS of 18.7 (range: 9.7-55.8) months. Salvage surgery after TKI or ICI treatment can be safely performed, and the OS may be favorable.