Primary Curative Therapy Research Articles

Salvage Reirradiation for Locally Recurrent Prostate Cancer: Results From a Prospective Study With 7.2 Years of Follow-Up.

There are no well-established re-treatment options for local recurrence after primary curative radiation therapy for prostate cancer (PCa), as prospective studies with long-term follow-up are lacking. Here, we present results from a prospective study on focal salvage reirradiation with external-beam radiation therapy with a median follow-up of 7.2 years. From 2013 to 2017, 38 patients with biopsy-proven locally recurrent PCa >2 years after previous treatment and absence of grade 2-3 toxicity from the first course of radiation were included. The treatment was 35 Gy in five fractions to the MRI-based target volume and 6 months of androgen-deprivation therapy starting 3 months before radiation. The Phoenix criteria defined biochemical recurrence-free survival (bRFS), and toxicity was scored according to Radiation Therapy Oncology Group criteria. Median age was 70 years, and median time from primary radiation to prostate-specific antigen (PSA) recurrence was 83 months. The actuarial 2-year and 5-year bRFS were 81% (95% CI, 69 to 94) and 58% (95% CI, 49 to 74), respectively. The actuarial 5-year local recurrence-free survival was 93% (95% CI, 82 to 100), metastasis-free survival was 82% (95% CI, 69 to 95), and overall survival was 87% (95% CI, 76 to 98). Two patients (5%) had durable grade 3 genitourinary toxicity, one combined with GI grade 3 toxicity. A PSA doubling time ≤6 months at salvage, a Gleason score >7, and a PSA nadir ≥0.1 ng/mL predicted a worse outcome. Reirradiation with EBRT for locally recurrent PCa after primary curative radiation therapy is clinically feasible and demonstrated a favorable outcome with acceptable toxicity in this prospective study with long-term follow-up.

Principles of Surgical Management of Peritoneal Mesothelioma.

Malignant peritoneal mesothelioma (MPeM) is a rare malignancy and represents 5% to 30% of malignant mesothelioma cases. The primary curative therapy for MPeM is radical cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC), with the strongest predictor of long-term survival being complete cytoreduction. There is a paucity of high-quality evidence available to guide management in MPeM; however, NCCN Guidelines for the management of MPeM were updated this year. In well-selected patients, 5-year overall survival exceeds 65%, but achieving optimal results requires careful preoperative evaluation and expert surgical management. Preoperative patient selection includes histology review and staging with cross-sectional imaging. Ideal candidates for curative intent surgery are those with epithelioid MPeM, a low peritoneal cancer index, and a good performance status. Contraindications to curative intent surgery include the sarcomatoid MPeM, distant metastases, extensive nodal metastases, and extensive small bowel serosal or mesentery involvement not amenable to complete cytoreduction. Those with biphasic histology, bicavitary disease, and metastatic lymphadenopathy may be considered for surgery following response to neoadjuvant therapy. CRS involves resection of all peritoneal disease, the extent of which varies case by case. Key aspects involve careful evaluation of all peritoneal surfaces, complete parietal peritonectomy and omentectomy, and evaluating suspicious abdominal lymph node basins. Once maximum cytoreduction is achieved, HIPEC is performed using a platinum-based perfusate. Postoperative protocols are recommended to optimize recovery and mitigate HIPEC-specific complications, namely chemotherapy-mediated nephrotoxicity and bone marrow suppression.

Discontinuing Hepatitis Activity Reduced Hepatocellular Carcinoma Recurrence after Primary Curative Therapy

Hepatocellular carcinoma (HCC) tends to recur after curative treatment. This study aimed to identify the clinical factors associated with HCC recurrence after initial curative therapy. We retrospectively included patients with early stage HCC Barcelona Clinic Liver Cancer (BCLC) stages 0 and A who received curative surgical resection or local ablation at three different Chang Gung Memorial Hospitals in Taiwan (527 patients from Linkou, 150 patients from Keelung, and 127 patients from Chiayi) from 2000 to 2009. Pretreatment clinical data were subjected to univariate and multivariate logistic analyses to identify the risk factors for HCC recurrence within five years after the primary curative treatment. Recurrence and survival rates were assessed using Kaplan-Meier curves and log-rank tests. Patients with a history of nucleoside analog or peg-interferon treatment for hepatitis B or hepatitis C infection had lower HCC recurrence rates than did those without such treatment. By contrast, alcohol drinking habits (p = 0.0049, hazard ratio (HR): 1.508, 95%CI: 1.133-2.009), a platelet count of < 14 × 104/μL (p = 0.003, HR: 1.533, 95%CI: 1.155-2.035), and a serum alanine aminotransferase level > 40 U/L (p = 0.0450, HR: 1.305, 95%CI: 1.006-1.694) were independent risk factors for HCC recurrence. The five-year HCC recurrence rates did not differ between patients who received either local radiofrequency ablation or surgical resection at BCLC stages 0 and A. Factors contributing to persistent hepatitis activity and advanced fibrosis precipitate tumor recurrence. Active intervention to discontinue liver injury or hepatitis could reduce HCC recurrence.

The Women’s Health Initiative cancer survivorship clinic incorporating electronic patient-reported outcomes: a study protocol for the Linking You to Support and Advice (LYSA) randomized controlled trial

BackgroundThe improved survival rate for many cancers in high-income countries demands a coordinated multidisciplinary approach to survivorship care and service provision to ensure optimal patient outcomes and quality of life. This study assesses the feasibility of introducing a Women’s Health Initiative cancer survivorship clinic in Ireland.MethodsThe trial comprises an intervention and control arm. Two hundred participants will be recruited. Key eligibility (1) women with early-stage hormone receptor-positive breast or gynecologic cancer (cervix or endometrial), within 12 months of completion of primary curative therapy, and (2) access to the Internet.The complex intervention comprises a nurse-led clinic targeting symptom management through a trigger alert system, utilizing electronic patient-reported outcome (ePRO) assessments at baseline, and 2, 4, 6, 8, 10, and 12 months. It also includes input from a dietitian monitoring diet and nutritional status.The control group will receive their usual care pathway standard of care and attend the cancer survivorship clinic and complete ePRO assessments at the start and end of the study.The primary endpoint (feasibility) includes the proportion of enrolled participants who complete baseline and follow-up ePRO surveys and partake in health professional consultations after ePRO data triggers. Secondary endpoints include changes in cancer-related symptom scores assessed by ePROs, health-related Quality of Life Questionnaire (QLQ) scores, Appraisal Self-Care Agency-R scores, and adjuvant endocrine therapy medication adherence. A process evaluation will capture the experiences of participation in the study, and the healthcare costs will be examined as part of the economic analysis.Ethical approval was granted in December 2020, with accrual commencing in March 2021.DiscussionThis protocol describes the implementation of a parallel arm randomized controlled trial (RCT) which examines the feasibility of delivering a Cancer Survivorship Clinic. The ePRO is an innovative symptom monitoring system which detects the treatment-related effects and provides individualized support for cancer survivors. The findings will provide direction for the implementation of future survivorship care.Trial registrationClinicalTrials.gov, NCT05035173. Retrospectively registered on September 5, 2021

350. SALVAGE RADIATION THERAPY FOR OLIGO-RECURRENCES AFTER RADICAL TREATMENT OF ESOPHAGEAL CANCER

Abstract Loco-regional recurrences following surgery or radical radiation therapy for esophageal cancers represent a significant clinical problem. We performed a retrospective study to assess the safety and efficacy of salvage radiation for oligo-recurrence after primary curative therapy for esophageal cancer. Esophageal cancer patients treated with salvage radiotherapy between January 2011 and March 2020 at our institution were screened. Patients were included if they had undergone prior treatment for esophageal carcinoma with curative intent using either surgery or radiotherapy and had developed local/locoregional/isolated distant recurrences. Recurrences were diagnosed based on CT scan or/and FDG PET-CT scan. Treatment plan was discussed in a multi-disciplinary tumour board and patients were followed up as per institution policy. Survival rates were estimated using the Kaplan–Meier method and data was analyzed using IBM SPSS Statistics for Windows (Version 26.0. Armonk, NY: IBM Corp.) Oligo-recurrence was diagnosed in 33 patients; thirty patients had loco-regional-recurrence (LRR), 3 had distant metastasis); 28 patients underwent surgery as initial treatment; 5 received definitive RT. Recurrence was detected at a median of 21 months. Of the 30 patients with LRR, 25 patients received chemo-radiation and 5 received RT alone. At a median follow-up of 18 months, 20 patients were alive and 61% had controlled disease. Overall survival at 1- &amp; 2- year were 83% and 65% respectively. Concurrent chemotherapy administration and RT dose of &amp;gt;56Gy were independent predictors for OS. No grade 3/4 acute or chronic toxicity were observed. Salvage RT with or without concomitant chemotherapy for loco-regional recurrences after surgery for esophageal cancer is safe and effective. Advanced, modern RT techniques may reduce treatment related morbidity and improve outcomes.

Morbidity and Oncological Outcome After Curative Treatment in Sinonasal Squamous Cell Carcinoma.

Sinonasal squamous cell carcinomas are rare and aggressive tumors. Curative therapy includes surgery and radiotherapy, with high risk for local morbidity and impaired quality of life. The objective of this study was to analyze a large cohort of patients with sinonasal squamous cell carcinoma on treatment morbidity and oncological outcome. Patients with sinonasal squamous cell carcinoma (n = 75) treated at a tertiary referral center between 2008 and 2019 were identified. In patients with curative treatment intent (n = 70), a chart review and analysis on patient and tumor characteristics, morbidity, and oncological outcome was performed. Mean follow-up was 59months. Primary curative therapy was surgery alone (n = 18), surgery with radiation (n = 25), and primary (chemo)radiation (n = 27). Forty-two (60%) patients suffered from treatment-related morbidity; most frequent symptoms were dry nasal mucosa (20%), nasal obstruction (14.3%), and vision impairment or loss (11.5%). Patients with early disease had less morbidity (51.4 vs 71.1%; P = 0.09), a lower recurrence rate (27% vs. 48.5%; P = 0.08), and better overall survival (92.5% vs. 71.1%; P = 0.01). Treatment-related morbidity is common after curative treatment of sinonasal squamous cell carcinomas. Early disease is beneficial in terms of occurrence and severity as multimodal treatment and recurrence can more likely be avoided.

Post-allogeneic stem cell transplant FLT3- targeted maintenance therapy: updates and considerations for clinical practice.

Acute myeloid leukemia (AML) is characterized by multiple molecular and cytogenetic abnormalities, with increasing data to support clinical and prognostic implications to guide clinical decision making. One of the most well described mutations involves fms-like tyrosine kinase 3 (FLT3) that results in a constitutively active tyrosine kinase and is generally associated with poor prognosis involving shorter overall survival and higher rates of relapse. Advancements in targeted therapies have greatly influenced available treatment options in a landscape that has remained largely unchanged for the past five decades. Tyrosine kinase inhibitors (TKI), specifically FLT3-targeted therapies, are now integral treatment options for patients with this targetable mutation. As allogeneic hematopoietic cell transplant (alloHCT) remains the primary curative therapy for most adult AML patients, the goal is for eligible patients to proceed to transplant. However, post-alloHCT relapse remains exceedingly high even in patients achieving deep responses to therapy. Limited evaluation of FLT3-targeted TKIs as post-alloHCT maintenance therapy in FLT3-positive patients suggest improved outcomes and tolerable safety profiles, with ongoing studies further investigating second-generation agents. Thus, this commentary aims to review the role of post-alloHCT FLT3-targeted maintenance therapy and considerations for clinical practice.

A phase I does-escalation and expansion study of epidiolex (cannabidiol) in patients with biochemically recurrent prostate cancer.

257 Background: There is a need for a low toxicity option for men with prostate cancer with biochemical recurrence (BCR) following primary curative therapy. Cannabinoids (CBD) have anti-tumor activity in preclinical studies, but products may vary in activity without clear standardization. As epidiolex is a standardized FDA approved oral CBD solution for treatment of certain types of seizures, we studied epidiolex in patients with BCR of prostate cancer to determine safety and dosing of this therapy to support future studies. Methods: We present an open-label, single center, phase I dose escalation study followed by a dose expansion. Patients with BCR prostate cancer after primary definitive local therapy (prostatectomy +/- salvage radiotherapy or primary definitive radiotherapy) were eligible. Majority of our patients’ prostate-specific antigen (PSA) doubling time was ≤ 12 months. All patients were screened for urine tetrahydrocannabinol (THC) prior to enrollment. With use of a Bayesian optimal interval design, patients received escalating doses of epidiolex starting at 600mg daily and up to 800mg daily. All patients were treated for 90 days followed by a 10 day taper. The Primary endpoints were safety and tolerability. Patients were monitored for both acute (30 days) and chronic (90 days) treatment-related toxicities. Secondary endpoints included change in PSA levels and testosterone levels from baseline throughout the treatment period. Results: A total of 21 patients were enrolled but four withdrew from the study (one patient was hospitalized with COVID-19 and three patients requested to stop due to grade 2 adverse events (AEs). There were seven patients included in the dose escalation phase. Four patients received 600mg daily; two of the four in this phase did not finish the first 30 days (one with COVID-19 and one withdrew). The other three patients received 800 mg daily. No dose-limiting toxicities were observed at any dose level so an additional 14 patients were enrolled at the 800mg dose. Treatment-related chronic AEs occurring in &gt;10% of patients were grade 1 or 2 diarrhea (47.6%), grade 1 or 2 nausea (23.8%) and grade 1 or 2 fatigue (19%). The mean PSA at baseline was 2.9 ng/ml. One patient developed oligo-metastasis disease, two patients progressed after the study period, and one patient died from a non-treatment or disease-related cause. Conclusions: Epidiolex at a dose of 800mg daily appears to be safe and tolerable in patients with BCR of prostate cancer, supporting a safe dose for future studies to determine if there is clinical activity to delay development of hormone refractory metastatic disease. Clinical trial information: NCT04428203.

Salvage lymph node dissection for prostate-specific membrane antigen (PSMA) positron emission tomography (PET)-identified oligometastatic disease.

The availability of prostate-specific membrane antigen (PSMA) positron emission tomography (PET)/computed tomography (CT) imaging, particularly in the setting of rising prostate-specific antigen (PSA) after definitive treatment, has led to oligometastatic prostate cancer being increasingly identified. Despite the enthusiasm surrounding treating oligometastatic disease, it has been relatively understudied. We sought to review our salvage lymphadenectomy experience in the PSMA PET/CT era. We retrospectively reviewed patients undergoing lymphadenectomy following curative-intent primary therapy with rising PSA who had undergone a PSMA PET/CT identifying oligometastatic disease (defined as ≤5 PSMA-avid lesions) between January 2016 and April 2020. The primary endpoint was complete response, defined as achieving a PSA <0.2 ng/ml without concomitant androgen deprivation therapy (ADT). Twenty-two patients were included. Primary curative therapy included radical prostatectomy (86.4%) and brachytherapy (13.6%). Median PSA at salvage surgery was 1.72 ng/ml. Pelvic lymph node dissection was the most performed procedure (72.7%). Median node yield was 10.5, with a median of 1.5 positive nodes on pathology. Eight patients (36.4%) achieved PSA <0.2, with six (27.3%) remaining with PSA <0.2 after a median followup of 23.1 months. Nine (40.9%) had an initial PSA decline, but nadired ≥0.2, and in five (22.7%) the PSA rose immediately after surgery. Overall, ADT was started in seven patients (31.8%) at a median of 10.1 months post-salvage surgery. In our series of salvage dissection for PSMA-PET-detected nodal oligometastases, approximately a third achieved PSA <0.2; yet, it was only durable in 27%. Prospective trials of salvage nodal radiation are ongoing, however, more prospective trials of salvage node dissection are needed.

Oligometastatic Disease Management: Finding the Sweet Spot.

Hematogenous dissemination represents a common manifestation of squamous cell carcinoma of the head and neck, and the recommended therapeutic options usually consist of systemically administered drugs with palliative intent. However, mounting evidence suggests that patients with few and slowly progressive distant lesions of small size may benefit from various local ablation techniques, which have already been established as standard-of-care modalities for example in colorectal and renal cell carcinomas and in sarcomas. In principle, serving as radical approaches to eradicate cancer, these interventions can be curative. Their impact on local control and overall survival has been shown in numerous retrospective and prospective studies. The term oligometastatic refers to the number of distant lesions which should generally not surpass five in total, ideally in one organ. Currently, surgical resection remains the method of choice supported by the majority of published data. More recently, stereotactic (ablative) body radiotherapy (SABR/SBRT) has emerged as a viable alternative. In cases technically amenable to such local interventions, several other clinical variables need to be taken into account also, including patient-related factors (general health status, patient preferences, socioeconomic background) and disease-related factors (primary tumor site, growth kinetics, synchronous or metachronous metastases). In head and neck cancer, patients presenting with late development of slowly progressive oligometastatic lesions in the lungs secondary to human papillomavirus (HPV)-positive oropharyngeal cancer are the ideal candidates for metastasectomy or other local therapies. However, literature data are still limited to say whether there are other subgroups benefiting from this approach. One of the plausible explanations is that radiological follow-up after primary curative therapy is usually not recommended because its impact on survival has not been unequivocal, which is also due to the rarity of oligometastatic manifestations in this disease. At the same time, aggressive treatment of synchronous metastases early in the disease course should be weighed against the risk of futile interventions in a disease with already multimetastatic microscopic dissemination. Therefore, attentive treatment sequencing, meticulous appraisal of cancer extension, refinement of post-treatment surveillance, and understanding of tumor biology and kinetics are crucial in the management of oligometastases.

Cost-utility analysis of surveillance strategies for soft tissue sarcoma recurrence.

11565 Background: Soft tissue sarcomas (STS) are uncommon malignancies with significant biological and clinical variation. After primary curative therapy, patients enter a program of surveillance for recurrence with periodic chest x-rays (CXR) or computed tomography (CT). We compared costs and health outcomes of CXR and CT at a range of frequencies and durations of follow-up. Methods: We used a Markov model to simulate a cohort of 10,000 STS patients through their surveillance experience for lung metastasis after completion of definitive treatment for stage II or III primary disease. Health states in the model were no evidence of disease, recurrence, and death. We assessed the method of chest imaging, duration of follow-up, and interval (every 3 months or 6 months) of surveillance in the first 3 years. Cost effectiveness was assessed for each screening modality and screening frequency. Recurrence probabilities, utilities, treatment costs, and other parameters were from previously published data. Outcomes were costs, quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios (ICER). Results: The initial evaluation comparing screening every 3 months for 3 years, every 6 months for years 4 and 5, and annually from years 6 to 10 resulted in 632,264 QALYs and $1,038,351,481 costs for CT, compared to 631,834 QALYs and $746,019,937 for CXR, resulting in an ICER of $679,322/QALY. In comparing screening intervals, less frequent screening intervals of every 6 months compared to every 3 months for the first three years using CT resulted in an ICER of $690,527/QALY and for CXR, the ICER was $271,423/QALY. In comparing screening duration between 6 years and 10 years of follow-up, strategies with longer follow-up resulted in slightly higher QALYs in each of the comparison scenarios, at a much higher cost. Conclusions: In our evaluation, more frequent screening the first 3 years and longer duration of surveillance resulted in higher QALYs in both screening modalities. However, in the comparisons the ICERs exceed common willingness to pay thresholds of $150,000/QALY gained; CXR is the more cost-effective imaging modality. Limitation of this model includes the simplification of disease progression and heterogeneity in STS.

Comparison of 68Ga-PSMA-11 PET/CT with 11C-acetate PET/CT in re-staging of prostate cancer relapse

Positron emission tomography (PET) imaging is used to localize recurrent disease in prostate cancer (PCa). The tracer 68Ga-PSMA-11 visualizes lesions overexpressing prostate-specific membrane antigen (PSMA), while 11C-acetate visualizes lesions with increased anabolic metabolism. The aim of this study was to compare the performance of PSMA-PET and acetate-PET in re-staging patients with biochemical relapse. Thirty PCa patients with prostate-specific antigen (PSA) relapse after primary curative therapy were prospectively evaluated. PET/CT examinations using 11C-acetate and 68Ga-PSMA-11 were performed. Identified lesions were categorized according to anatomical location and PET measurements were correlated with PSA at time of scan. Tumour lesions showed higher semi-quantitative uptake values on PSMA-PET than acetate-PET. PSMA-PET identified more lesions in 11 patients, fewer lesions in eight patients, and identical number of lesions in 11 patients. This study indicates better diagnostic performance of PSMA-PET, particularly in detecting lymph node (81% vs 60%, p = 0.02) and bone metastasis (95% vs 61%, p = 0.0001) compared to acetate-PET. However, 38% of PSMA-expressing metastases appear to be metabolically inactive and 15% of metabolically active metastases lack PSMA expression. Addition of PET with a metabolic tracer, such as 11C-acetate, might be beneficial before making treatment decisions.

Radioablation +/\u2212 hormonotherapy for prostate cancer oligorecurrences (Radiosa trial): potential of imaging and biology (AIRC IG-22159)

BackgroundProstate cancer (PCa) is the second most common cancer among men. New imaging-modalities have increased the diagnosed patients with limited number of metastasis after primary curative therapy, introducing so-called oligometastatic state. Stereotactic body radiotherapy (SBRT) is emerging as a low-toxicity treatment to erase PCa localizations and postpone androgen deprivation therapy (ADT). A deeper understanding of the predictive role of biomarkers is desirable for a targeted treatment selection and surveillance programs. The aims of the RADIOSA trial are:Compare SBRT +/− ADT for oligorecurrent-castration-sensitive PCa (OCS-PCa) in terms of efficacy, toxicity and Quality of Life (QoL).Develop biology/imaging based prognostic tool that allows identifying OCS-PCa subclasses.MethodsThis is a randomized phase II clinical trial, recruiting 160 OCS-PCa in 3 years, with progression-free survival (PFS) as primary endpoint. Three tasks will be developed:Randomized clinical study (3 years for accrual and 2 years for follow-up and data analysis);Imaging study, including imaging registration and METastasis Reporting and Data System (MET-RADS) criteria;Pre-clinical study, development of a biobank of blood samples for the analysis of neutrophil-to-lymphocyte ratio and preparatory for a subsequent miRNA profiling.We aim to determine which arm is justified for testing in a subsequent Phase III trial. A decision-tree algorithm, based on prognosis, biological phenotype and imaging profile, will be developed.DiscussionRecruiting will start in July 2019. SBRT will allow obtaining excellent PFS, local control, QoL and low toxicity. In SBRT arm, ADT deferral will allow for a drug-holiday, delaying the detrimental impact on QoL. A sufficient number of blood samples will be collected to perform biological patient profiling. A stratification tool will be established with an analysis of morphological and functional imaging, based on the use of MET-RADS criteria.So, in conclusion, RADIOSA aims to define the optimal management of bone/nodal PCa relapses in a SBRT regimen. This study will increase our knowledge on low-burden metastatic PCa in the era of high precision and high technology personalized medicine, offering highly effective therapy in terms of clinical outcome and cost-effectiveness.Trial registrationThe RADIOSA study was prospectively registered at clinicaltrials.gov (NCT03940235, May 2019).

Surveillance and outcomes after curative resection for gastroesophageal adenocarcinoma (GEAC).

162 Background: Although commonly performed, the benefit of routine surveillance testing (SvT) following curative resection of GEAC is undefined. We aimed to determine frequency of successful salvage therapy (SST) in patients (pts) with relapsed GEAC who were surveyed post curative therapy. Methods: Between 2011 and 2016, 210 consecutive pts with locally advanced GEAC underwent curative surgery and subsequent surveillance at Princess Margaret Cancer Center. SST was defined as any potentially curative therapy for recurrence which resulted in post-recurrence survival (PRS) two years without further relapse. Time-to-event outcomes were analyzed using Kaplan-Meier and Cox regression methods. Results: Median age was 64.1 years. Esophageal (14%), gastroesophageal junction (41%), and gastric adenocarcinomas (45%) were included. Pts received surgery alone (29%), surgery with perioperative chemotherapy (26%) or perioperative chemoradiation (45%) as primary curative therapy. At median follow-up of 33.6 months (m, range 6.0-122.4), 3- and 5-year overall survival (OS) rates were 68% (95% CI 61-75%) and 59% (95% CI 51-68%) respectively. SvT modalities included imaging (69%), endoscopy (19%), tumor markers (4%), and clinical visits only (9%). Recurrences occurred in 95 (45%) pts, 51% were surveillance-detected (SvDR), and 47% were non-SvDR. Types of recurrences included locoregional only (4%), distant (87%) or both (9%). Salvage therapy was attempted in 14 pts (7%) with SvDR and 1 with non-SvDR. In four pts with SvDR (1.9%) salvage therapy was successful with chemoradiation or surgery perioperative chemotherapy, six were unsuccessful, and 5 had immature follow-up. Compared with pts with non-SvDR, pts with SvDR had longer median OS (34.8 vs. 24.0m, p=0.03) and PRS (14.4 vs. 4.8m, p &lt; 0.001), and similar time-to-relapse (15.6 vs. 12.0m, p = 0.67). Palliative chemotherapy was administered in 25 pts with SvDR and 18 pts with non-SvDR with similar median duration (3.5m vs. 3.3m, p=0.64). Conclusions: Following curative therapy, 96% of relapses were distant. SvT enabled SST in only 1.9% of pts, and did not extend duration of palliative chemotherapy. These data do not support the use of routine SvT in resected GEAC.

1272P - Outcome of an active surveillance programme for patients (pts) with uveal melanoma (UM) after primary curative therapy (PTx): Single institution 10-year experience

1272P - Outcome of an active surveillance programme for patients (pts) with uveal melanoma (UM) after primary curative therapy (PTx): Single institution 10-year experience

Percutaneous Ablation for Hepatocellular Carcinoma.

The purpose of this article is to discuss the use, comparative efficacy, and general technical considerations of percutaneous ablation, alone or in combination with other therapies, for the treatment of hepatocellular carcinoma (HCC). Percutaneous ablation is a mainstay treatment for early-stage HCC, offering survival comparable to that of surgical resection for small lesions. It can act as a primary curative therapy or bridge therapy for patients waiting to undergo liver transplant. New ablation modalities and combining tumor ablation with other therapies, such as transarterial chemoembolization, can improve clinical outcomes and allow treatment of larger lesions. Combining thermal ablation with systemic chemotherapy, including immunotherapy, is an area of future development.

1240P - Impact of an active surveillance programme on outcome of patients (pts) with uveal melanoma (UM) after primary curative therapy (PTx): results of a single-institution experience

1240P - Impact of an active surveillance programme on outcome of patients (pts) with uveal melanoma (UM) after primary curative therapy (PTx): results of a single-institution experience

Development of standardized image interpretation for 68Ga-PSMA PET/CT to detect prostate cancer recurrent lesions.

After primary treatment, biochemical relapse (BCR) occurs in a substantial number of patients with prostate cancer (PCa). PET/CT imaging with prostate-specific membrane antigen based tracers (68Ga-PSMA) has shown promising results for BCR patients. However, a standardized image interpretation methodology has yet to be properly agreed. The aim of this study, which was promoted and funded by European Association of Nuclear Medicine (EANM), is to define standardized image interpretation criteria for 68Ga-PSMA PET/CT to detect recurrent PCa lesions in patients treated with primary curative intent therapy (radical prostatectomy or radiotherapy) who presented a biochemical recurrence. In the first phase inter-rater agreement between seven readers from seven international centers was calculated on the reading of 68Ga-PSMA PET/CT images of 49 patients with BCR. Each reader evaluated findings in five different sites of recurrence (local, loco-regional lymph nodes, distant lymph nodes, bone, and other). In the second phase the re-analysis was limited to cases with poor, slight, fair, or moderate agreement [Krippendorff's (K) alpha<0.61]. Finally, on the basis of the consensus readings, we sought to define a list of revised consensus criteria for 68Ga-PSMA PET/CT interpretation. Between-reader agreement for the presence of anomalous findings in any of the five sites was only moderate (K's alpha: 0.47). The agreement improved and became substantial when readers had to judge whether the anomalous findings were suggestive for a pathologic, uncertain, or non-pathologic image (K's alpha: 0.64). K's alpha calculations for each of the five sites of recurrence were also performed and evaluated. First Delphi round was thus conducted. A more detailed definition of the criteria was proposed by the project coordinator, which was then discussed and finally agreed by the seven readers. After the second Delphi round only four cases of disagreement still remained. These were evaluated for a final round, allowing a final agreement table to be written. We hope that by developing these consensus guidelines on the interpretation of 68Ga-PSMA PET/CT, clinicians reporting these studies will be able to provide more consistent clinical reports and that within clinical trials, abnormality classifications will be harmonized, allowing more robust assessment of its diagnostic performance.

An integrative approach to personalized cancer survivorship care at an academic medical center.

37 Background: Quality cancer survivorship care has multiple missions 1) develop personalized disease-specific treatment summaries (TS) and evidence-based survivorship plans (SPs), 2) foster recognition amongst Primary Care Providers (PCPs) of the consequences of cancer and its therapy, 3) coordinate care amongst providers, 4) use technology to foster communication and mining data, 5) train residents/fellows, 6) determine knowledge gaps for research, 7) engage community health providers, 8) publicize and raise funds, and 9) develop metrics to assess outcomes. Here we describe initial steps toward these goals. Methods: The University of Rochester Judy DiMarzo Cancer Survivorship program is a multidisciplinary effort across 7 centers involving oncologists, PCPs, social workers, integrated oncology, legal/financial services, and survivors. Survivors are identified at two critical time points: after (1) completion of primary curative therapy = transition visit, (2) discontinuation of routine oncologic follow-up and transition of care to their PCP = shared care visit. These visits are staffed within each cancer discipline. Trainees (15-20/year) probe existing evidence and draft TS/SP templates that are vetted by that cancer discipline. Patient needs are surveyed; institutional and community resources are identified. Results: In 3 years, 1037 patients had survivorship visits - 859 transition visits, 178 shared care visits. Cancers include breast (31%), head &amp; neck (17%), lymphoma (15%), GI (15%), GU (11%), GYN (7%), lung (3%), melanoma and sarcoma (1%) with continuing refinement of systematic patient identification. Visits by year were: 120 in 2013, 266 in 2014, and 470 in 2015. Amongst the 1037 patients, the 6 most common needs were exercise, emotional, return to work, nutrition, financial, and pain. Conclusions: Our program is systematically embracing challenges to deliver evidence-based, individualized TS/SPs for survivors, as well as train future oncology providers in survivorship care. Current areas of focus are better engaging PCPs, ensuring program sustainability, improving technology use to mine data, measuring outcomes, establishing rural outreach, and fostering survivorship research.

Evaluation of the EGFR-Inhibitor Zalutumumab Given With Primary Curative (Chemo)radiation Therapy to Patients With Squamous Cell Carcinoma of the Head and Neck: Results of the DAHANCA 19 Randomized Phase 3 Trial: Definitive Management of Head-and-Neck Squamous Cell Carcinoma

Evaluation of the EGFR-Inhibitor Zalutumumab Given With Primary Curative (Chemo)radiation Therapy to Patients With Squamous Cell Carcinoma of the Head and Neck: Results of the DAHANCA 19 Randomized Phase 3 Trial Definitive Management of Head-and-Neck Squamous Cell Carcinoma J.G. Eriksen, C. Maare, J. Johansen, H. Primdahl, J.F. Evensen, C.A. Kristensen, L.J. Andersen, and J. Overgaard,; Odense University Hospital, Odense, Denmark, Herlev Hospital, Herlev, Denmark, Aarhus University Hospital, Aarhus C, Denmark, Oslo University Hospital, Oslo, Norway, Copenhagen University Hospital, Copenhagen, Denmark, Aalborg University Hospital, Aalborg, Denmark