Purpose: Neoadjuvant chemotherapy is an effective method for down-staging the primary tumor before surgery. However, some of patients do not respond. In these patients, neoadjuvant chemotherapy is just an ineffective, toxic and expensive procedure. Therefore, it is very important to find the reliable method to differentiate the responder from non-responder as early as possible. In order to evaluate the role of magnetic resonance imaging (MRI) for the assessment of tumor response, we examined the correlation between the early MRI changes after the 1st cycle of neoadjuvant chemotherapy and later pathologic response after the 3rd cycle of neoadjuvant chemotherapy.Patients and method: 31 breast cancer patients who underwent neoadjuvant chemotherapy prior to surgery were analyzed. The baseline MRI was taken before neoadjuvant chemotherapy. Anthracycline plus taxane were administered to all patients. Post-chemotherapy MRI assessment was done just before the 2nd cycle of neoadjuvant chemotherapy. If the primary tumor was reduced more than 20% in the product of the longest and perpendicular diameter, those cases were classified as responders. Surgery was performed after the 3rd cycle of neoadjuvant chemotherapy. The pathologic response was assessed by measuring pathologic tumor size of viable tumor cells. Sensitivity, specificity, positive predictive value, and negative predictive value of MRI findings were calculated on the basis of histopathological examination.Results: Total 31 patients were examined. Of these patients, 2 patients had bilateral breast cancer. Therefore, a total of 33 lesions were evaluated. The median tumor size on baseline MRI was 4.5cm (range:2.1-10.0cm). 27 cases were classified as responders on early MRI findings. Of these cases, pathologic response was confirmed in 26 cases after surgery. Six cases were classified as non-responder on MRI. In this group, 3 cases showed pathologic response and 3 cases did not. Sensitivity, specificity, positive predictive value and negative predictive value of early MRI findings for the prediction of pathologic response were 89.7%, 75.0%, 96.3% and 50.0%, respectively.Conclusion: Post-chemotherapy MRI after the 1st cycle of neoadjuvant chemotherapy could differentiate responders from non-responders with high accuracy. It would be helpful to determine whether the chemotherapy regimen should be continued or not in the early phase of neoadjuvant therapy. Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 6057.
1.1). Results: Four levels of the dose escalation part are finalized (nZ17): 6 pts at 10% (2 SBRT doses tested due to organs constraints), 4 pts at 15 and 22% (due to fiducial displacement and ILI shift) and 3 pts at 33%. No NBTXR3 related early DLT or SAE were observed. Indeed only one NBTXR3 related AE (G1 fatigue at 33%) was reported. There were no significant changes in CPS or APRI post-treatment. CT-scan assessment demonstrated absence of NBTXR3 leakage in surrounding tissues. Among 7 evaluable HCC pts, best mRECIST target lesion responses were: 3 CR, 4 PR. Among 5 evaluable mets pts, best target lesion responses were: 2 PR, 1 SD, 2 PD. Conclusion: NBTXR3 was well tolerated up to the 33% dose level and demonstrated a very good safety profile. The very good tolerance and preliminary anti-tumor effects have supported a protocol amendment to study an additional higher NBTXR3 dose level (42%). Indeed recent data reinforces this further escalation as OS and local control seem to depend on RT dose and tumor volume. Liver dysfunction is the limiting factor for treatment in these pts, hence, this innovative physics based approach may constitute a valuable solution for pts with unresectable liver tumors. NBTXR3 showed statistically superior efficacy over RT alone in a phase II/III trial in soft tissue sarcoma [NCT02379845] and is currently being evaluated in phase I/II trials: head and neck [NCT01946867; NCT02901483], prostate [NCT02805894] and rectal cancers [NCT02465593].
Hospital in Lusaka, Zambia (CDH), an international virtual clinical research course for clinical oncology fellows at CDH was piloted in Fall 2020 to address a significant need for a structured clinical research curriculum. Materials/Methods: The virtual clinical research course took place from August to November 2020 and involved 14 weekly hour-long lectures (13 by MDA faculty, one by CDH faculty) on topics including identifying a research question, study design, clinical trials, research ethics, biostatistics, and scientific writing. The course was attended by 15 clinical oncology fellows. Eight senior fellows were paired with a longitudinal MDA and CDH faculty member and MDA resident/fellow mentor in their area of interest to support a research protocol. Anonymized pre-and post-course surveys were administered with 5-point Likert scale academic self-efficacy inventories and open-ended qualitative questions. Descriptive statistics were used to summarize the findings. Results: A total of 12/15 participants (80%) completed the pre-course survey and 11/15 (73%) completed the post-course survey. Average scores pre-and post-course, respectively, for research interest and motivation (5.0, 4.9), comfort reading and evaluating medical literature (3.7, 4.5), developing a study question and design (2.8, 4.0), collecting and managing data (3.3, 4.0), independently performing and publishing research (2.3, 3.7), and satisfaction with mentorship and profession (3.0, 4.2) demonstrated an increase across multiple domains. As of December 2020, there were eight active research proposals led by CDH clinical oncology fellows and there had been 21 meetings and 27 hours of MDA-CDH mentorship time.Positive themes from open-ended feedback included clear lectures, meaningful relationships with mentors, and utility of presenting research proposals for feedback while constructive themes included desire for more teaching on statistical analysis and incorporation of self-assessment modules.Conclusion: Clinical research is essential to develop effective, evidencebased interventions to the unique cancer care challenges that occur in LMICs. The results from the pilot virtual MDA-CDH research course, which led to improvements in academic self-efficacy scores, support for research proposals led by CDH clinical oncology fellows, and formation of longitudinal mentorship groups demonstrate the feasibility of conducting a virtual longitudinal research workshop model. Continued collaboration and future follow-up will be needed to demonstrate effectiveness and impact.
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