Background Standard therapy for locally advanced rectal cancer (LARC) is pre-operative chemo-radiotherapy (CRT) and post-operative chemotherapy. We began offering FOLFOX (5FU, leucovorin and oxaliplatin) as initial treatment for patients with high-risk LARC to target micrometastases, while treating the primary tumor. Purpose To report safety and efficacy of initial FOLFOX before CRT on tumor downsizing and pathologic complete response (pathCR) in LARC. Patients and Methods IRB waiver was obtained to review records of stage II/III rectal cancer patients (pts) treated at MSKCC between 2007 and 2012. Of approximately 300 LARC pts treated with CRT, 61 received FOLFOX as initial therapy. Results Of the 61 pts, 57 received induction FOLFOX (median 7 cycles) then CRT, 4 pts had an excellent response, declined CRT, and had total mesorectal excision. Twelve pts did not undergo TME; 9 had a complete clinical response (CCR); 1 declined despite persistent tumor, 1 due to comorbidities, 1 developed metastatic disease. 22/61 patients (36%) had either pathCR (n=13) or CCR (n=9). Of the 49 pts who underwent TME, all had R0 resections, 23 (47%) had tumor response >90%, including 13 (27%) pathCR. 28 pts received all 8 cycles of FOLFOX, 8 had pathCR (29%) and 3 CCR (11%). There were no serious adverse events requiring delay in treatment during FOLFOX or CRT. Conclusion FOLFOX and CRT before planned TME results in tumor regression, a high rate of delivery of planned therapy, substantial rate of pathCRs and offers a good platform for potential non-operative management in select patients.
IMPORTANCE Surgical resection has been considered the only curative option for patients with pancreatic cancer. Nonoperative local treatment options that can provide a similar benefit are needed. Emerging radiation techniques that address organ motion have enabled curative radiation doses to be given in patients with inoperable disease. OBJECTIVE To determine the association of hypofractionated ablative radiation therapy (A-RT) with survival for patients with locally advanced pancreatic cancer (LAPC) treated with a novel radiation planning and delivery technique. DESIGN, SETTING, AND PARTICIPANTSThis cohort study included 119 consecutive patients treated with A-RT between June 2016 and February 2019 and enrolled in a prospectively maintained database. Patients were treated with a standardized technique within a large academic cancer center regional network. All patients with localized, unresectable, or medically inoperable pancreatic cancer with tumors of any size and less than 5 cm luminal abutment with the primary tumor were eligible.INTERVENTIONS Ablative RT (98 Gy biologically effective dose) was delivered using standard equipment. Respiratory gating, soft tissue image guidance, and selective adaptive planning were used to address organ motion and limit the dose to surrounding luminal organs. MAIN OUTCOMES AND MEASURES The primary outcome was overall survival (OS). Secondary outcomes included incidence of local progression and progression-free survival.RESULTS Between 2016 and 2019, 119 patients (59 men, median age 67 years) received A-RT, including 99 with T3/T4 and 53 with node-positive disease, with a median carbohydrate antigen 19-9 (CA19-9) level greater than 167 U/mL. Most (116 [97.5%]) received induction chemotherapy for a median of 4 months (0.5-18.4). Median OS from diagnosis and A-RT were 26.8 and 18.4 months, respectively. Respective 12-and 24-month OS from A-RT were 74% (95% CI, 66%-83%) and 38% (95% CI, 27%-52%). Twelve-and 24-month cumulative incidence of locoregional failure were 17.6% (95% CI, 10.4%-24.9%) and 32.8% (95% CI, 21.6%-44.1%), respectively. Postinduction CA19-9 decline was associated with improved locoregional control and survival. Grade 3 upper gastrointestinal bleeding occurred in 10 patients (8%) with no grade 4 to 5 events.CONCLUSIONS AND RELEVANCE This cohort study of patients with inoperable LAPC found that A-RT following multiagent induction therapy for LAPC was associated with durable locoregional tumor control and favorable survival. Prospective randomized trials in patients with LAPC are warranted.
Radiotherapy (RT) can be curative in patients with localized follicular lymphoma (FL), with historical series showing a 10-year disease-free survival of 40 to 50%. As 18F-fluorodeoxyglucose (18F-FDG) positron emission tomography with computerized tomography (PET-CT) upstages 10 to 60% of patients compared to CT, we sought to evaluate outcomes in patients staged by PET-CT, to determine if more accurate staging leads to better patient selection and results. We conducted a multicenter retrospective study under the direction of the International Lymphoma Radiation Oncology Group (ILROG). Inclusion criteria were: RT alone for untreated stage I to II FL (grade 1-3A) with dose equivalent ≥24 Gy, staged by PET-CT, age ≥18 years, and follow-up ≥3 months. End points were freedom from progression (FFP), local control, and overall survival (OS). A total of 512 patients treated between 2000 and 2017 at 16 centers were eligible for analysis; median age was 58 years (range, 20-90); 410 patients (80.1%) had stage I disease; median RT dose was 30 Gy (24-52); and median follow-up was 52 months (3.2-174.6). Five-year FFP and OS were 68.9% and 96%. For stage I, FFP was 74.1% vs 49.1% for stage II (P < .0001). Eight patients relapsed in-field (1.6%). Four had marginal recurrences (0.8%) resulting in local control rate of 97.6%. On multivariable analysis, stage II (hazard ratio [HR], 2.11; 95% confidence interval [CI], 1.44-3.10) and BCL2 expression (HR, 1.62; 95% CI, 1.07-2.47) were significantly associated with less favorable FFP. Outcome after RT in PET-CT staged patients appears to be better than in earlier series, particularly in stage I disease, suggesting that the curative potential of RT for truly localized FL has been underestimated.
646 Background: Pelvic radiotherapy with concurrent 5-fluorouracil based chemotherapy (chemoradiation) is a component of standard therapy for patients with T3/T4 or node-positive rectal cancer. Chemoradiation can be associated with significant acute gastrointestinal toxicity. This study sought to retrospectively compare patient and clinician reports of acute symptoms experienced by rectal cancer patients receiving chemoradiation. Methods: The charts of 199 rectal cancer patients who received chemoradiation from 11/06 to 2/11 were reviewed. Clinicians assessed toxicity weekly using Common Terminology for Clinical Adverse Event (CTCAE) version 3.0. Patient-reported outcomes (PROs) were collected weekly, in clinic, beginning 9/09 using the 7-item Bowel Problems Scale. 197 patients had at least one clinician assessment or PRO and were eligible for this study. Patient and clinician assessments were compared among a subgroup of 65 patients (paired group) who had at least one patient and clinician assessment on the same date using descriptive statistics. Agreement between patient and clinician assessments was evaluated by Cohen’s kappa coefficient. Results: Characteristics were well-balanced between all rectal patients and the paired group, with the exception of the use of intensity modulated radiotherapy (IMRT). IMRT has been used increasingly over time, and IMRT was therefore used in a larger proportion of the paired group versus all patients (77% vs. 51%, respectively). Diarrhea and proctitis were reported more often by patients than clinicians throughout treatment. Uncorrected agreement for diarrhea and proctitis was 82% and 72%, respectively. Corrected for chance, Cohen’s kappa was .64 for diarrhea, indicating moderate agreement, and .22 for proctitis, indicating only slight agreement. Conclusions: Our findings suggest a discrepancy between clinician and patient symptom reports. Further study is warranted to discern potential benefits of including PROs in prospective studies, and to find whether PROs can help clinicians set patient expectations, and/or enhance communication for optimal symptom management.
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