Sphenopalatine ganglion block (SPGB) is a technique developed in the 1990s for the management of head and neck pain patients. Recently, transnasal sphenopalatine ganglion block (TN-SPGB) has been widely used for these patients; however, no objective methods exist for validating the success of TN-SPGB. In this study, we measured the changes in facial temperature before and 30 minutes after TN-SPGB by using digital infrared thermal imaging (DITI) to validate its success. The medical records of patients, who underwent TN-SPGB and facial DITI between January 2016 and December 2017, were reviewed. TN-SPGB and facial DITI were performed 36 times in 32 patients. The changes in facial temperatures measured at the forehead (V1), maxillary area (V2), and mandibular area (V3) by using DITI before and 30 minutes after TN-SPGB were recorded and compared. The temperatures on the ipsilateral and contralateral sides of these areas were also compared. The comparison between pain relief group and pain maintenance group was analyzed. After TN-SPGB, the temperature decreased significantly on both sides of V1 ( P = .0208, 0.0181). No significant differences were observed between the ipsilateral and contralateral sides ( P > .05). There was no correlation between changes in temperature and changes in pain score in the pain regions after the procedure ( P > .05). The temperature decreased significantly in V1 area at 30 minutes after TN-SPGB compared with the temperature before TN-SPGB. Based on these results, we propose using DITI to measure temperature changes as an objective method for verifying the success of TN-SPGB.
Background Nilotinib is a tyrosine kinase inhibitor approved by the Ministry of Food and Drug Safety for frontline and 2nd line treatment of Philadelphia chromosome-positive chronic myeloid leukemia (Ph + CML). This study aimed to confirm the safety and efficacy of nilotinib in routine clinical practice within South Korea. Methods An open-label, multicenter, single-arm, 12-week observational post-marketing surveillance (PMS) study was conducted on 669 Korean adult patients with Ph + CML from December 24, 2010, to December 23, 2016. The patients received nilotinib treatment in routine clinical practice settings. Safety was evaluated by all types of adverse events (AEs) during the study period, and efficacy was evaluated by the complete hematological response (CHR) and cytogenetic response. Results During the study period, AEs occurred in 61.3% (410 patients, 973 events), adverse drug reactions (ADRs) in 40.5% (271/669 patients, 559 events), serious AEs in 4.5% (30 patients, 37 events), and serious ADRs in 0.7% (5 patients, 8 events). Furthermore, unexpected AEs occurred at a rate of 6.9% (46 patients, 55 events) and unexpected ADRs at 1.2% (8 patients, 8 events). As for the efficacy results, CHR was achieved in 89.5% (442/494 patients), and minor cytogenetic response or major cytogenetic response was achieved in 85.8% (139/162 patients). Conclusion This PMS study shows consistent results in terms of safety and efficacy compared with previous studies. Nilotinib was well tolerated and efficacious in adult Korean patients with Ph + CML in routine clinical practice settings.
2044 Background: Induction treatment followed by autologous stem cell transplantation (ASCT) is the standard therapy for the newly diagnosed younger patients with multiple myeloma (MM). Although new drugs such as lenalidomide or bortezomib have been shown the promising results as induction treatment, many different type of induction treatment regimens still have been used. We evaluate the efficacy and safety of the short course of high dose dexamethasone (HD dexa) and the response adapted PAD (Bortezomib, Adriamycin, Dexamethasone) or VAD (Vincristine, Adriamycin, Dexamethasone) induction chemotherapy in the newly diagnosed younger patients with MM. Methods: 107 newly diagnosed patients with MM from 21 institutions received 2nd cycles of HD dexa followed by PAD or VAD chemotherapy according to the response to the initial high dose dexamethasone. The primary endpoint was complete response (CR) + near CR rate after ASCT. Among 107 patents enrolled this study from November 2009, 25 patients (23%) have been dropped out. This trial will be continued until total 210 patients will be enrolled. The trial is registered on National Cancer Institute website, number NCT01255514. Results: One hundred seven patients (58 male, 49 female) were enrolled (median age; 56). 26 (24%) light chain disease were included. 31 (29%) patients were D-S stage II and 67 (63%) were stage III. According to the ISS, 23 (22%) patients had stage I, 51 (48%) had stage II and 33 (31%) had stage III. 26 (24%) patients had abnormal cytogenetics. There were 31% del13, 7% del17, 19% t(4;14), 15% t(14;16) and 28% t(11;14) in FISH analysis. Among the 82 evaluable patients, CR + PR rate was 48% (39/82) after 2nd cycles of HD dexa therapy. 39 patients (48%) received subsequent VAD chemotherapy and 43 patients (52%) received PAD chemotherapy. Among the 64 patients finished VAD or PAD chemotherapy, CR + PR rate was 83% (79%, 26/33 in VAD group vs. 87%, 27/31 in PAD group). 56 patients were finished ASCT until now. CR + near CR rate after ASCT were 61% (58% in VAD group vs 63% in PAD group). Mortality rate of this trial was 13% (11/82). The cause of death was disease progression (n=3), bleeding (n=1) and infections (n=7). Among 82 patients in whom VAD or PAD chemotherapy was actually performed, 1 year overall survival (OS) rate was 84.7%. 1 year survival rate was 93.8% versus 77.2% (P=0.049) with VAD versus PAD (median follow-up; 9.1 months). Conclusion: Risk adapted approach using initial steroid response showed good response results after ASCT compared with previous trial (CR + near CR rate of IFM 2005-01trial-Bortezomib+dexa induction & ASCT was 35%, J Clin Oncol. 2010;28:4621–9) The MM patients who had poor response to HD dexa also showed similar good response rate after ASCT compared with the patients who had good response to HD dexa treatment in this trial. PAD re-induction therapy after failure of initial steroid induction treatment might overcome the inferior results in the high risk MM patients. Therefore, initial steroid response adapted strategy might be the more cost-effective approach in the newly diagnosed ASCT eligible MM patients. Disclosures: No relevant conflicts of interest to declare.
3106 Background: Induction therapy followed by ASCT is the standard therapy for the newly diagnosed younger patients with MM. Recently, new drugs such as lenalidomide or bortezomib have shown the promising results as an induction treatment. However, these drugs are not available in many countries as a front line treatment and many different type of induction treatment regimens including old regimens are used. We evaluate the efficacy and safety of the brief course of high dose dexamethasone (HD) and the response adapted PAD (Bortezomib, Adriamycin, Dexamethasone) or VAD (Vincristine, Adriamycin, Dexamethasone) induction chemotherapy in the newly diagnosed younger patients with MM. Methods: One hundred fifty five newly diagnosed patients with MM from 23 institutions received 2 cycles of HD followed by PAD or VAD chemotherapy according to the response to the HD. PAD 4 cycles were given to nonresponsders and VAD 2 cycles were given to who achieved more than PR to HD. The primary endpoint was CR + nCR rate after ASCT. Among 155 patents enrolled this study from November 2009, 29 patients (19%) have been dropped out. This trial will be continued until total 210 patients will be enrolled. The trial is registered on National Cancer Institute website, number NCT01255514. Results: One hundred fifty five patients (88 male, 69 female) were enrolled (median age; 57). 34 (22%) patients had ISS stage I, 64 (41%) stage II and 55 (35%) stage III. Thirty six (26%) patients had abnormal cytogenetics. In FISH analysis, there were 25% del13, 9% del17, 21% t (4; 14), 13% t (14; 16) and 26% t (11; 14). Among the 115 evaluable patients, CR + PR rate was 53% (61/115) after 2 cycles of HD. 61 patients (53%) received subsequent VAD chemotherapy and 54 patients (47%) received PAD chemotherapy. Among the evaluable patients, CR + PR rate after induction therapy was 83% (79%, 48/61 in VAD group vs. 89%, 48/54 in PAD group). 95 patients finished ASCT. CR + nCR rate after ASCT were 74% (74% in VAD group vs 73% in PAD group). Mortality rate of this trial was 15% (17/115). The cause of death was disease progression (n=5), bleeding (n=1) and infections (n=11). Among 115 patients in whom VAD or PAD chemotherapy was actually performed, 1 year OS was 88.1%. (VAD arm 90.7% versus PAD arm 86.1% (P=0.105): median follow-up; 16.6 months). Conclusion: Risk adapted approach using initial HD response showed good response results after ASCT compared with previous trial (CR + nCR rate of IFM 2005-01 trial-Bortezomib+dexa induction & ASCT was 35%, J Clin Oncol. 2010;28:4621–9) The MM patients who showed poor response to HD also showed similar good response rate after ASCT compared with the patients who had good response to HD in this trial. PAD re-induction therapy after failure of initial steroid induction treatment might overcome the inferior results in the high risk MM patients. Our data shows that almost half of the patients who responded to HD can be saved of novel agents during induction treatment, and PAD can successfully rescue the other half who are not sensitive to HD. Therefore, initial steroid response adapted strategy might be the more cost-effective approach in the newly diagnosed ASCT eligible MM patients. Disclosures: No relevant conflicts of interest to declare.
FDG-PET, a functional imaging modality used for staging and monitoring response to treatment of malignant lymphoma, has a higher sensitivity and specificity than conventional imaging. PET/CT may be more accurate than conventional imaging in assessing treatment effects to correctly identify patients with residual disease and predict therapy outcomes. We prospectively investigated that PET/CT may provide additional prognostic information in mid-response assessment prior to completion of chemotherapy. Patients and Method: Eighty-six newly diagnosed patients with malignant lymphoma were enrolled from Aug. 2004 to July 2006. Both CT and PET/CT analysis were performed at the time of diagnosis and after the 3rd or 4th chemotherapy. The clinical stage of the patients was assessed according to International Workshop Criteria (IWC). PET/CT imaging was analyzed according to the combination of morphology using the CT portion and by the uptake and location of the FDG-PET portion. The cut off value of the positive in PET/CT was more than max SUV 3.0. We divided them into four different response groups using IWC and PET/CT (CRu-negative, Cru-positive, PR-negative, PR-positive). The limited-stage patients were treated with chemotherapy and involved field radiation therapy and the advanced-stage patients were treated with eight cycles of chemotherapy. However, advanced-stage patients who were older than sixty, if they had CRu-negative in interim analysis, were treated with only six cycles. Results: Median age was 53.5 years (range: 19 – 85). Seventy five patients had Non-Hodgkin’s lymphoma [Indolent-11 (12.8%), Aggressive-64 (74.4%)] and eleven patients (12.8%) had Hodgkin’s lymphoma. Forty-two patients (48.8%) achieved CRu-negative, 6 patients (7.0%) achieved CRu-positive, 20 patients (23.3%) achieved PR-negative and 18 patients (20.9%) showed PR-positive by interim IWC and PET/CT. The relapse rate is significantly different between PET-positive (58.3%) and PET-negative (8.1%) (P=0.000), especially when 12 of 18 patients in PR-positive group (66.7%) relapsed after or during chemotherapy. Figures showed the Kaplan-Meier estimates of overall and progression free survival of 86 patients depending on the combined evaluation of interim IWC and PET/CT. Conclusion: Interim PET/CT analysis was a significantly predictive value of disease progression and survival. The patients with PR-positive according to interim IWC and PET/CT analysis should be considered for an intensive therapeutic plan. Figure Figure
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