A Pattern of Care Report on the Management of Patients with Squamous Cell Carcinoma of the Anus—A Study by the Italian Association of Radiotherapy and Clinical Oncology (AIRO) Gastrointestinal Tumors Study Group

Background and objectives: The diagnosis and therapy of squamous cell carcinoma of the anus may vary significantly in daily clinical practice, even if international guidelines are available. Materials and Methods: We conducted a pattern of care survey to assess the management of patients with anal cancer in Italy (38 questions). We analyzed 58 questionnaires. Results: Most of the respondents work in public and/or university hospitals (75.8%) in northern Italy (65.5%). The majority (88.0%) treat less than 20 patients/year. Common examinations for diagnosis and staging are anorectal endoscopy (84.5%), computed tomography scan (86.2%) and pelvic magnetic resonance imaging (MRI) (96.5%). The most frequently prescribed dose to primary tumor is 50–54 Gy (46.5–58.6%) for early stage disease and 54–59.4 Gy (62.1–32.8%) for locally advanced cases. Elective volumes are prescribed around 45 Gy (94.8%). Most participants use volumetric intensity modulated radiotherapy (89.7%) and a simultaneous integrated boost (84.5%). Concurrent radiotherapy, 5-fluorouracil and mitomycin is considered the standard of care (70.6%). Capecitabine is less frequently used (34.4%). Induction chemotherapy is an option for extensive localized disease (65.5%). Consolidation chemotherapy is rarely used (18.9%). A response evaluation is conducted at 26–30 weeks (63.9%) with a pelvic MRI (91.4%). Follow-up is generally run by the multidisciplinary tumor board (62.1%). Conclusions: Differences were observed for radiotherapy dose prescription, calling for a consensus to harmonize treatment strategies.

NCOG-08. BIOPSY-ONLY GLIOBLASTOMA (BO-GBM) AS A HETEROGENEOUS GROUP OF PATIENTS

BACKGROUND “Biopsy-only” glioblastoma is associated with a heterogeneous functional and survival outcome. It is an understudied group of patients which has been reported to represent 21% of histologically confirmed GBM in the US National Cancer Data Base. Pattern of care included radiotherapy-temozolomide (RT-TMZ) completed in 15% of patients, any other form of oncologic treatment in 60%, and supportive care alone in 25% of patients. Our objective was to explore treatment and prognosis of BO-GBM. MATERIAL AND METHODS Patients with BO-GBM included in a prospective regional glioma SIRIC cohort in 2014-2017 were retrospectively reviewed for patient characteristics, MRI finding, treatment allocation and delivery. PFS and OS were analyzed. RESULTS Of 535 patients included in the cohort, 449 patients were included at initial surgery, of which 158 patients (35%) underwent biopsy only. Of 158 patients, 18 were excluded for missing data leaving 139 patients for the present analysis. Fifty-four (39%) were referred to RT-TMZ, 68 (49%) considered unfitted for RT received chemotherapy upfront (CT-UF), 17 (12%) were referred to palliative care. Groups differed at baseline for age (mean 60 and 68 years, for RT-TMZ, CT-UF respectively); KPS (70, 60 for RT-TMZ, CT-UF); mean tumor surface (793, 1420 mm2 for RT-TMZ, CT-UF); and tumor extension (bilateral in 6.4% and 29.3% for RT-CT and CT-UF respectively). Median OS was 14 months (95% CI, 9.65-18.71) and 8 months (95% CI, 4.62-7.67) for RT-TMZ, CT-UF respectively. CONCLUSION Inoperable GBM constitute a large and heterogeneous population in which one third of patients are amenable to standard of care, with survival outcome close to the one of patients who underwent surgery. Patients considered unfit for RT-CT at diagnosis exhibit a poor survival outcome. Thus, reliable criteria are needed to help selecting patients for adequate treatment while new strategies are warranted for BO-GBM unfit for RT.

Evolving Frontline Immunochemotherapy for Mantle Cell Lymphoma and the Impact on Survival Outcomes

With the advances in mantle cell lymphoma (MCL) frontline treatment over the last two decades, we sought to characterize the frontline treatment pattern change and its association with outcomes. Patients with newly diagnosed MCL from September 2002 through June 2015 were enrolled in a prospective cohort study, and clinical characteristics, treatment, and clinical outcomes were compared between patients diagnosed in 2002-2009 (Era 1) vs 2010-2015 (Era 2). Patient age, sex and simplified MIPI score were similar between the two groups. In patients with an age ≤65, there were less use of R-Hyper-CVAD (16.1% vs 8.8%) but more Nordic and R-CHOP/R-DHAP regimens (1.1% vs 26.4%), and less use of R-CHOP/R-CHOP-like regimen (64.5% vs 35.2%) but more R-Bendamustine (0% vs 12.1%) in Era 2 (p<0.001). These changes were associated with improved EFS (5-year 34.3% vs 50.0%, p=0.010) and OS (5-year 68.8% vs 81.6%, p=0.017) in Era 2. In patients with an age >65, there were less use of R-CHOP/R-CHOP-like (39.0% vs 14.3%) and non-standard systemic therapy (36.6% vs 13.0%) but more R-Bendamustine (0% vs 49.4%). These changes were associated with a trend for improved EFS (5-year 25.4% vs 37.5%, p=0.051) in Era 2. The shift from R-CHOP/R-CHOP-like regimen to R-Bendamustine was associated with improved EFS (5-year 25.0% vs 44.6%, p=0.008) in Era 2. Results from this prospective cohort study provide critical real-world evidence for improved outcomes with evolving frontline pattern of care in patients with MCL.

Dissecting patterns of care in patients with variant histology of bladder cancer and lymph node invasion

Objectives Lymph node invasion (LNI) is related to long-term survival in patients with muscle-invasive bladder cancer. However, in the case of variant histology (VH), data on pelvic lymph node dissection (PLND) and LNI are sparse. We described the pattern of care of PLND in patients with VHs of bladder cancer, exploring predictors of LNI. Methods Using the 2001–2016 SEER registry, 20 767 bladder cancer patients who underwent PLND were identified. Included histological variants were pure urothelial carcinoma (UC), micropapillary UC, sarcomatoid UC, lymphoepithelioma-like UC, adenocarcinoma, sarcoma, giant and spindle cell carcinoma, squamous cell carcinoma (SCC), and neuroendocrine tumor. Uni- and multivariable logistic regression analyses tested for LNI predictors. Cox regression was used to test for predictors of overall mortality (OM) among both LNI positive and LNI negative patients. Results Overall, 2464 (11.9%) harbored a VH. On multivariate analysis, only micropapillary UC was associated with higher risk (OR = 3.39) of LNI. This association was maintained when only the subset of patients treated without perioperative chemotherapy were analyzed (OR = 3.30). Similarly, higher T stage (T2 stage OR = 2.24; T3–4 stage OR = 9.44) and the use of chemotherapy (OR = 2.29) were associated with a higher risk of LNI. Among patients with LNI (5299, 25.5%), SCC (HR = 1.87), T3–4 stage (HR = 1.94), age at diagnosis (HR = 1.01) and geographic region (south) (HR = 1.22) were predictors of higher risk of OM. Conversely, chemotherapy (HR = 0.69) and number of removed LN (HR = −0.99) were associated with lower risk of OM. Finally, in a subgroup of patients without LNI, sarcomatoid UC (HR = 1.58) and giant and spindle cell carcinoma (HR = 1.83) were the only VH predictors of OM. Conclusions We described different patterns of care in patients with VHs of bladder cancer. Micropapillary UC was an independent risk factor for LNI. Among patients harboring LNI, those with SCC VH had higher OM compared to pure UC. Conversely, sarcomatoid UC and giant and spindle cell carcinoma were predictors of OM in patients without nodal involvement.

Demographics, Pattern of Care, and Outcome Analysis of Malignant Melanomas - Experience From a Tertiary Cancer Centre in India

BackgroundTreatment of malignant melanoma has undergone a paradigm shift with the advent of immune checkpoint inhibitors (ICI) and targeted therapies. However, access to ICI is limited in low-middle income countries (LMICs).Patients and MethodsHistologically confirmed malignant melanoma cases registered from 2013 to 2019 were analysed for pattern of care, safety, and efficacy of systemic therapies (ST).ResultsThere were 659 patients with a median age of 53 (range 44–63) years; 58.9% were males; 55.2% were mucosal melanomas. Most common primary sites were extremities (36.6%) and anorectum (31.4%). Nearly 10.8% of the metastatic cohort were BRAF mutated. Among 368 non-metastatic patients (172 prior treated, 185 de novo, and 11 unresectable), with a median follow-up of 26 months (0–83 months), median EFS and OS were 29.5 (95% CI: 22–40) and 33.3 (95% CI: 29.5–41.2) months, respectively. In the metastatic cohort, with a median follow up of 24 (0–85) months, the median EFS for BSC was 3.1 (95% CI 1.9–4.8) months versus 3.98 (95% CI 3.2–4.7) months with any ST (HR: 0.69, 95% CI: 0.52–0.92; P = 0.011). The median OS was 3.9 (95% CI 3.3–6.4) months for BSC alone versus 12.0 (95% CI 10.5–15.1) months in any ST (HR: 0.38, 95% CI: 0.28–0.50; P < 0.001). The disease control rate was 51.55%. Commonest grade 3–4 toxicity was anemia with chemotherapy (9.5%) and ICI (8.8%). In multivariate analysis, any ST received had a better prognostic impact in the metastatic cohort.ConclusionsLarge real-world data reflects the treatment patterns adopted in LMIC for melanomas and poor access to expensive, standard of care therapies. Other systemic therapies provide meaningful clinical benefit and are worth exploring especially when the standard therapies are challenging to administer.

P04.08 Biopsy-only glioblastoma (BO-GBM) as a heterogeneous group of patients

BACKGROUND “Biopsy-only” glioblastoma is associated with a heterogeneous functional and survival outcome. BO-GBM patients is an understudied group of patients associated to a poor outcome, which has been reported to represent 21% of histologically confirmed GBM in the US National Cancer Data Base. Pattern of care included radiotherapy-temozolomide (RT-TMZ) standard regimen completed in 15% of patients, any other form of oncologic treatment in 60%, and supportive care alone in 25% of patients. Our objective was to explore pattern of care and prognosis associated to BO-GBM in our center. MATERIAL AND METHODS Patients with BO-GBM included in a prospective regional glioma SIRIC cohort initiated in 2014 and closed in 2017 were retrospectively reviewed for patients characteristics, MRI finding, treatment allocation and delivery. PFS and OS were analyzed. RESULTS Of 535 patients included in the cohort, 86 patients were referred > 3 months post-surgery and were excluded from this analysis while 449 patients were included at initial surgery, of which 158 patients (35%) underwent biopsy only. Of 158 patients, 18 patients were excluded for missing data leaving 139 patients for the present analysis. Fifty-four (39%) were referred to RT-TMZ (50 patients completed concomitant treatment), 68 (49%) considered unfitted for RT received chemotherapy upfront (CT-UF) (of which 4 were subsequently referred to RT), 17 (12%) were referred to palliative care only (PC). Groups differed at baseline for age (mean 60, 68, and 69 years, for RT-TMZ, CT-UF, and PC respectively); for KPS (70, 60, and 50 for RT-TMZ, CT-UF, and PC respectively); for mean tumor surface measured on gadolinium-enhanced T1-weighted (793, 1420, 1412 mm2 for RT-TMZ, CT-UF, PC); for tumor extension (bilateral in 6.4% and 29.3% for RT-TMZ and CT-UF respectively); for mean steroid intake (45, 60, 100 mg daily respectively). Median OS was 14 months (95% CI, 9.65–18.71), 8 months (95% CI, 4.62–7.67), and 2 months (95% CI, 0.67–3.33) for RT-TMZ, CT-UF, and PC respectively. CONCLUSION Inoperable GBM constitute a large and heterogeneous population in which one third of patients are amenable to standard of care, with survival outcome close to the one of patients who underwent surgery. Patients considered unfit for RT-TMZ at diagnosis fail to be referred subsequently to RT after CT and exhibit a poor survival outcome. Thus, reliable criteria are needed to help selecting patients for adequate treatment while new strategies are warranted for BO-GBM unfit for RT.