scholarly journals Treatment of cutaneous lichen planus with ALA-mediated topical photodynamic therapy

2015 ◽  
Vol 08 (01) ◽  
pp. 1540004 ◽  
Author(s):  
Zhi-Xia Fan ◽  
Ling-Lin Zhang ◽  
Hong-Wei Wang ◽  
Pei-Ru Wang ◽  
Zheng Huang ◽  
...  
Keyword(s):  
Photodynamic Therapy ◽  
Side Effects ◽  
Lichen Planus ◽  
Clinical Assessment ◽  
Response Rate ◽  
Aminolevulinic Acid ◽  
Complete Response Rate ◽  
Complete Response ◽  
Chinese Patients

Purpose: To evaluate the effectiveness of topical 5-aminolevulinic acid (ALA)-mediated photodynamic therapy (PDT) for the treatment of cutaneous lichen planus (LP). Methods: A total of 17 symptomatic LP lesions in 7 Chinese patients were assessed. ALA cream (10%) was applied topically to LP lesions for 3 h. The lesions were irradiated with a 635 nm diode laser at the dose level of 100 J/cm2. The treatment was repeated at two-week intervals. Clinical assessment was conducted before each treatment. Follow-up was performed once a month for up to six months. Results: Lesions showed significant improvement after one to four courses of treatments. Complete response was achieved in 13 lesions (five patients) and partial remission in four lesions (two patients). The complete response rate was 71%. There was no significant side effects except the feeling of pain that most patients could tolerate. Follow-up of five patients who achieved complete response showed no signs of recurrence. Conclusion: Topical ALA PDT is effective in the treatment of cutaneous LP.

scholarly journals Response and relapse rates after treatment with long-acting somatostatin analogs in multifocal or recurrent type-1 gastric carcinoids: A systematic review and meta-analysis

2019 ◽  
Vol 8 (2) ◽  
pp. 140-147 ◽  
Author(s):  
Roberta Elisa Rossi ◽  
Pietro Invernizzi ◽  
Vincenzo Mazzaferro ◽  
Sara Massironi
Keyword(s):  
Systematic Review ◽  
Neuroendocrine Tumors ◽  
Response Rate ◽  
Complete Response Rate ◽  
Somatostatin Analogs ◽  
Complete Response ◽  
Long Acting ◽  
Cumulative Relapse Rate

Background Type-1 gastric neuroendocrine tumors represent a recurring disease and long-acting somatostatin analogs can inhibit both gastrin release and endocrine cell proliferation. The efficacy and timing of this treatment are still unclear. We performed a systematic review of the literature to clarify the role of somatostatin analog treatment in type-1 gastric neuroendocrine tumors. Methods A computerized literature search was performed using relevant keywords to identify all the pertinent articles published in the last 15 years. Results Eight studies were included in this systematic review on somatostatin analogs in type-1 gastric neuroendocrine tumors. A complete response rate ranged from 25–100%. When only the six prospective studies were considered, no significant heterogeneity was observed, and the pooled cumulative complete response rate was 84.5% (confidence interval 73.8–92.8). Three studies evaluated the type-1 gastric neuroendocrine tumor recurrence, with a cumulative relapse rate of 30.2% (confidence interval 13.1–50.6) after 34 months. Conclusion Somatostatin analogs, namely lanreotide and octreotide, have an excellent response rate, with a good safety profile in selected type-1 gastric neuroendocrine tumors, which cannot be safely managed by endoscopic follow-up or resection due to multiple or frequently recurring disease. After therapy discontinuation, the cumulative relapse rate observed after a median 34-month follow-up was relatively high (30.2%).

The VcR-CVAD Regimen Produces a High Complete Response Rate in Untreated Mantle Cell Lymphoma (MCL): First Analysis of E1405 – A Phase II Study of VcR-CVAD with Maintenance Rituximab for MCL.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 1661-1661 ◽  
Author(s):  
Brad S Kahl ◽  
Hailun Li ◽  
Mitchell R Smith ◽  
Randy D. Gascoyne ◽  
Elisabeth Paietta ◽  
...  
Keyword(s):  
Phase Ii ◽  
Research Funding ◽  
Response Rate ◽  
Complete Response Rate ◽  
Phase Ii Study ◽  
Cell Lymphoma ◽  
Complete Response ◽  
Mantle Cell ◽  
Grade 3

Abstract Abstract 1661 Poster Board I-687 Introduction One approach to improving outcomes in Mantle Cell Lymphoma (MCL) is to incorporate newer targeted agents into standard chemotherapy regimens. As the proteasome inhibitor bortezomib (Velcade‘) achieved a 33% response rate in relapsed MCL, we hypothesized that the incorporation of Velcade (Vc) into a modified R-hyperCVAD chemotherapy backbone would result in a high complete response rate (CR). The new regimen, VcR-CVAD, was tested for safety and efficacy in a phase II study within the Wisconsin Oncology Network (UW) and demonstrated a CR rate of 77% (Kahl, ASH 2008). To determine the safety and efficacy of this regimen in a cooperative group setting, we initiated E1405: a phase II study of VcR-CVAD with maintenance rituximab (MR) for untreated MCL. Methods Eligible patients had histologically confirmed, previously untreated MCL, PS 0-2, and adequate end organ function. The treatment plan included: Velcade 1.3 mg/m2 days 1 and 4, rituximab 375 mg/m2 IV day 1, cyclophosphamide 300 mg/m2 IV over 3 hrs q 12 hrs X 6 doses days 1-3, doxorubicin 50 mg/m2 continuous infusion over 48 hrs days 1-2, vincristine 1 mg IV day 3, dexamethasone 40 mg po days 1-4. Cycles were repeated every 21 days for 6 cycles and all patients received G-CSF support. Patients achieving SD, PR, or CR received MR administered as 4 weekly treatments every 6 months for 2 years (protocol therapy). Patients had an option to receive high dose chemotherapy and autologous stem cell transplantation (off protocol) rather than MR. The primary endpoint of the trial was the CR rate, incorporating PET imaging, to VcR-CVAD induction therapy. Results Seventy-six eligible patients were enrolled between 5/07 and 10/08. Baseline characteristics include median age 62 (40-76), 59M:17F, 91% stage III/IV, and 39% with elevated LDH. Sixty-four patients (84%) completed VcR-CVAD induction therapy. Reasons for treatment discontinuation included PD (1), toxicity (4), patient preference (2), and other/unknown (5). Response information is available on 74 patients while data is outstanding on 2 patients. The ORR was 96% (73/76; 95% CI, 89%-99%), CR rate 75% (57/76; 95% CI, 64%-84%) and the PR rate 21% (16/76; 95% CI, 13%-32%). Six of the PR patients were coded as such because of protocol violations in which a post-treatment bone marrow biopsy or PET scan was not obtained. The CR rate in the 68 completely restaged patients was 84%. Forty-four patients proceeded to planned MR while 21 patients went off protocol to SCT consolidation. Median follow up is currently too short (9 months) to assess PFS and OS. The major toxicity of the treatment regimen was expected myelosuppression. Grade 3-4 non hematologic toxicities were rare. No patients developed grade 3-4 neuropathy. There were no treatment related deaths. Conclusion The VcR-CVAD induction produced high overall response (96%) and CR rate (75%) in a representative MCL patient population treated on a cooperative group protocol. The CR rate was high and comparable to the UW pilot study (77%). No episodes of severe painful peripheral neuropathy were reported using the reduced vincristine dosage and the overall toxicity profile was very acceptable. Longer follow up is needed to determine if the high CR rate will translate into improved PFS and OS. Disclosures Kahl: Genentech: Consultancy, Research Funding; Millennium: Consultancy, Research Funding. Off Label Use: Bortezomib as front line treatment in MCL. Smith:Genentech: Research Funding; Millennium: Research Funding. Advani:Seattle Genetics, Inc.: Research Funding. Horning:Genentech: Honoraria, Research Funding.

Bortezomib-Melphalan-Prednisone-Thalidomide Followed by Maintenance With Bortezomib-Thalidomide Compared With Bortezomib-Melphalan-Prednisone for Initial Treatment of Multiple Myeloma: Updated Follow-Up and Improved Survival

2014 ◽  
Vol 32 (7) ◽  
pp. 634-640 ◽  
Author(s):  
Antonio Palumbo ◽  
Sara Bringhen ◽  
Alessandra Larocca ◽  
Davide Rossi ◽  
Francesco Di Raimondo ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Overall Survival ◽  
Response Rate ◽  
Complete Response Rate ◽  
Progression Free Survival ◽  
Complete Response ◽  
Free Survival ◽  
Grade 3 ◽  
To Receive

Purpose Bortezomib-melphalan-prednisone (VMP) has improved overall survival in multiple myeloma. This randomized trial compared VMP plus thalidomide (VMPT) induction followed by bortezomib-thalidomide maintenance (VMPT-VT) with VMP in patients with newly diagnosed multiple myeloma. Patients and Methods We randomly assigned 511 patients who were not eligible for transplantation to receive VMPT-VT (nine 5-week cycles of VMPT followed by 2 years of VT maintenance) or VMP (nine 5-week cycles without maintenance). Results In the initial analysis with a median follow-up of 23 months, VMPT-VT improved complete response rate from 24% to 38% and 3-year progression-free-survival (PFS) from 41% to 56% compared with VMP. In this analysis, median follow-up was 54 months. The median PFS was significantly longer with VMPT-VT (35.3 months) than with VMP (24.8 months; hazard ratio [HR], 0.58; P < .001). The time to next therapy was 46.6 months in the VMPT-VT group and 27.8 months in the VMP group (HR, 0.52; P < .001). The 5-year overall survival (OS) was greater with VMPT-VT (61%) than with VMP (51%; HR, 0.70; P = .01). Survival from relapse was identical in both groups (HR, 0.92; P = .63). In the VMPT-VT group, the most frequent grade 3 to 4 adverse events included neutropenia (38%), thrombocytopenia (22%), peripheral neuropathy (11%), and cardiologic events (11%). All of these, except for thrombocytopenia, were significantly more frequent in the VMPT-VT patients. Conclusion Bortezomib and thalidomide significantly improved OS in multiple myeloma patients not eligible for transplantation.

scholarly journals Optimized duration of antituberculosis treatment for managing female genital tuberculosis: real-world experience from a high prevalence region in Eastern China

2020 ◽  
Author(s):  
Jian Sun ◽  
Wenjie Wang ◽  
Jing Ding ◽  
Yusheng Cheng ◽  
Yunfeng Zhou ◽  
...  
Keyword(s):  
Side Effects ◽  
Response Rate ◽  
Complete Response Rate ◽  
Complete Response ◽  
Single Side ◽  
Female Genital Tuberculosis ◽  
Group A ◽  
Intent To Treat ◽  
Group B ◽  
Female Genital

Abstract Background Duration of antituberculosis therapy (ATT) for managing female genital tuberculosis (FGTB) is controversial with the intermittent regimen no more advocated. We therefore conducted a prospective, real-world research to compare 6 months and 9 months of ATT.Methods Between 2012 and 2018, 109 drug-susceptible patients newly diagnosed with FGTB and/or tuberculous peritonitis (genital, 13; peritoneal, 34; mixed, 62) received naïve treatment for 9-12 months and further 18-month follow-up. Data on disease features at baseline and long-term outcome (intent-to-treat) were compared between group A (aged 18-35 yr) and group B (aged 36-81 yr). Efficacy and side effects of treatment were compared within each group 6 months and 9 months from ATT initiation (per-protocol), respectively. Results In contrast to group B at baseline, group A had more clinical evidence predicting active tuberculosis (P < 0.05), severer performance of genital lesions and pelvic adhensions (P < 0.05), more signs of active pulmonary tuberculosis (P < 0.01), and less performance of only TBP (P < 0.01). Intent-to-treat analysis showed higher incidence of overall single side effects and poor compliance in group B (P < 0.05), and similar recurrence rate between 2 groups. Per-protocol analysis showed increased complete response rate (P < 0.01) and similar incidence of side effects (P > 0.05) in group A, similar complete response rate (P > 0.05) and increased incidence of overall single side effects (P < 0.05) in group B at 9-month duration.Conclusions Younger females with FGTB had a greater risk of systemic infection of tuberculosis compared to older ones. Nine-month ATT using daily therapy proved to be beneficial for younger patients at reproductive age. Six-month option was suitable for older patients for reducing side effects and poor compliance in the duration of treatment.

scholarly journals A New Light-Emitting, Fabric-Based Device for Photodynamic Therapy of Actinic Keratosis: Protocol for a Randomized, Controlled, Multicenter, Intra-Individual, Phase II Noninferiority Study (the Phosistos Study) (Preprint)

2018 ◽  
Author(s):  
Anne-Sophie Vignion-Dewalle ◽  
Henry Abi Rached ◽  
Elise Thecua ◽  
Fabienne Lecomte ◽  
Pascal Deleporte ◽  
...  
Keyword(s):  
Photodynamic Therapy ◽  
Phase Ii ◽  
Actinic Keratosis ◽  
Response Rate ◽  
Complete Response Rate ◽  
Red Light ◽  
Complete Response ◽  
Light Emitting ◽  
Randomized Controlled ◽  
Individual Phase

BACKGROUND Actinic keratosis (AK) is a common early in situ skin carcinoma caused by long-term sun exposure and usually develops on sun-exposed skin areas. Left untreated, AK may progress to squamous cell carcinoma. To prevent such risk, most clinicians routinely treat AK. Therapy options for AK include cryotherapy, topical treatments, curettage, excision surgery, and photodynamic therapy (PDT). OBJECTIVE The aim of this study is to assess the noninferiority, in terms of efficacy at 3 months, of a PDT protocol involving a new light-emitting device (PDT using the Phosistos protocol [P-PDT]) compared with the conventional protocol (PDT using the conventional protocol [C-PDT]) in the treatment of AK. METHODS In this randomized, controlled, multicenter, intra-individual, phase II noninferiority clinical study, subjects with AK of the forehead and scalp are treated with P-PDT on one area and with C-PDT on the contralateral area. In both areas, lesions are prepared and methyl aminolevulinate (MAL) is applied. Thirty minutes after MAL application, the P-PDT area is exposed to red light at low irradiance (1.3 mW/cm2) for 2.5 hours so that a light dose of 12 J/cm2 is achieved. In the control area (C-PDT area), a 37 J/cm2 red light irradiation is performed 3 hours after MAL application. Recurrent AK at 3 months is retreated. The primary end point is the lesion complete response rate at 3 months. Secondary end points include pain scores at 1 day, local tolerance at 7 days, lesion complete response rate at 6 months, cosmetic outcome at 3 and 6 months, and patient-reported quality of life and satisfaction throughout the study. A total of 45 patients needs to be recruited. RESULTS Clinical investigations are complete: 46 patients were treated with P-PDT on one area (n=285 AK) and with C-PDT on the contralateral area (n=285 AK). Data analysis is ongoing, and statistical results will be available in the first half of 2019. CONCLUSIONS In case of noninferiority in efficacy and superiority in tolerability of P-PDT compared with C-PDT, P-PDT could become the treatment of choice for AK. CLINICALTRIAL ClinicalTrials.gov NCT03076892; https://clinicaltrials.gov/ct2/show/NCT03076892 (Archived by WebCite at http://www.webcitation.org/779qqVKek) INTERNATIONAL REGISTERED REPOR DERR1-10.2196/12990

scholarly journals Optimized duration of antituberculosis treatment for managing female genital tuberculosis: real-world experience from a high prevalence region in Eastern China

2020 ◽  
Author(s):  
Jianghua Yang ◽  
Jian Sun ◽  
Wenjie Wang ◽  
Jing Ding ◽  
Yusheng Cheng ◽  
...  
Keyword(s):  
Side Effects ◽  
Response Rate ◽  
Complete Response Rate ◽  
Complete Response ◽  
Single Side ◽  
Female Genital Tuberculosis ◽  
Group A ◽  
Intent To Treat ◽  
Group B ◽  
Female Genital

Abstract Background Duration of antituberculosis therapy (ATT) for managing female genital tuberculosis (FGTB) is controversial with the intermittent regimen no more advocated. We therefore conducted a prospective, real-world research to compare 6 months and 9 months of ATT. Methods Between 2012 and 2018, 109 drug-susceptible patients newly diagnosed with FGTB and/or tuberculous peritonitis (genital, 13; peritoneal, 34; mixed, 62) received naïve treatment for 9–12 months and further 18-month follow-up. Data on disease features at baseline and long-term outcome (intent-to-treat) were compared between group A (aged 15–35 years) and group B (aged ≥ 36 years). Efficacy and side effects of treatment were compared within each group 6 months and 9 months from ATT initiation (per-protocol), respectively. Results In contrast to group B at baseline, group A had more clinical evidence predicting active tuberculosis (P < 0.05), severer performance of genital lesions and pelvic adhensions (P < 0.05), more signs of active pulmonary tuberculosis (P < 0.01), and less performance of only TBP (P < 0.01). Intent-to-treat analysis showed higher incidence of overall single side effects and poor compliance in group B (P < 0.05), and similar recurrence rate between 2 groups. Per-protocol analysis showed increased complete response rate (P < 0.01) and similar incidence of side effects (P > 0.05) in group A, similar complete response rate (P > 0.05) and increased incidence of overall single side effects (P < 0.05) in group B at 9-mo duration. Conclusions Younger females with FGTB had a greater risk of systemic infection of TB compared to older ones. Nine-month ATT using daily therapy proved to be beneficial for younger patients at reproductive age. Six-month option was suitable for older patients for improving the side effects and poor compliance in the duration of treatment.

Efficacy of Photodynamic Therapy for the Treatment of Bowen’s Disease: A Meta-Analysis of Randomized Controlled Trials

Dermatology ◽  
2021 ◽  
pp. 1-9
Author(s):  
Wen-Li Xue ◽  
Jia-Qi Ruan ◽  
Hong-Ye Liu ◽  
Hong-Xia He
Keyword(s):  
Photodynamic Therapy ◽  
Response Rate ◽  
Complete Response Rate ◽  
Meta Analysis ◽  
Complete Response ◽  
Risk Of Bias ◽  
Bowen’S Disease ◽  
Bowen's Disease ◽  
Randomized Controlled ◽  
Significant Difference

<b><i>Background:</i></b> Photodynamic therapy is an established treatment option for Bowen’s disease. Our meta-analysis was aimed at evaluating the efficacy and recurrence of photodynamic therapy or other topical treatments (5-fluorouracil, cryotherapy) and of photodynamic therapy alone or in combination with other therapies (ablative fractional CO<sub>2</sub> laser or plum-blossom needle) for the treatment of Bowen’s disease. <b><i>Methods:</i></b> Trials that met our inclusion criteria were identified from PubMed, EMBASE, Web of Science, and Cochrane Library databases, and meta-analyses were conducted with RevMan V.5.4. The risk of bias was estimated with the Cochrane Collaboration’s risk of bias tools. Complete response rate, recurrence, pain/visual analogue scale score, cosmetic outcome, and adverse events were considered as outcomes. <b><i>Results:</i></b> Of the 2,439 records initially retrieved, 8 randomized controlled trials were included in this meta-analysis. According to our analyses, photodynamic therapy exhibited a significantly higher complete response rate (RR = 1.36, 95% CI [1.01, 1.84], <i>I</i><sup>2</sup> = 86%, <i>p</i> = 0.04), less recurrence (RR = 0.53, 95% CI [0.30, 0.95], <i>I</i><sup>2</sup> = 0%, <i>p</i> = 0.03), and better cosmetic outcome (RR = 1.34, 95% CI [1.15, 1.56], <i>I</i><sup>2</sup> = 0%, <i>p</i> = 0.0002) compared with other treatments. Moreover, there was a significant difference between the complete response rate of photodynamic therapy combined with ablative fractional CO<sub>2</sub> laser and that of photodynamic therapy (RR = 1.85, 95% CI [1.38, 2.49], <i>I</i><sup>2</sup> = 0%, <i>p</i> &#x3c; 0.0001). Photodynamic therapy combined with ablative fractional CO<sub>2</sub> laser or plum-blossom needle also showed significantly less recurrence (RR = 0.21, 95% CI [0.09, 0.51], <i>I</i><sup>2</sup> = 0%, <i>p</i> = 0.0005) and a lower visual analogue scale score (RR = 0.51, 95% CI [0.06, 0.96], <i>I</i><sup>2</sup> = 0%, <i>p</i> = 0.03) than photodynamic therapy alone. However, there was no significant difference in the complete response rate between photodynamic therapy combined with ablative continuous CO<sub>2</sub> laser and photodynamic therapy combined with ablative fractional CO<sub>2</sub> laser (RR = 1.00, 95% CI [0.54, 1.86], <i>I</i><sup>2</sup> not applicable, <i>p</i> = 1.00). <b><i>Conclusions:</i></b> This meta-analysis shows that photodynamic therapy can be used in the treatment of Bowen’s disease with better efficacy, less recurrence, and better cosmetic outcomes than cryotherapy and 5-FU. Some methods, including ablative fractional CO<sub>2</sub> laser, can be applied in combination with photodynamic therapy to improve efficacy. However, which laser-assisted photodynamic therapy scheme has the most advantages in the treatment of Bowen’s disease warrants further exploration.

CO2 LASER PLUS PHOTODYNAMIC THERAPY VERSUS CO2 LASER IN THE TREATMENT OF CONDYLOMA ACUMINATUM: A RANDOMIZED COMPARATIVE STUDY

2012 ◽  
Vol 05 (01) ◽  
pp. 1150008 ◽  
Author(s):  
HUIFENG LIU ◽  
PING ZHANG ◽  
XIANGJIE AN ◽  
LIU YANG ◽  
YAN LI ◽  
...  
Keyword(s):  
Photodynamic Therapy ◽  
Adverse Effects ◽  
Co2 Laser ◽  
Aminolevulinic Acid ◽  
Complete Response Rate ◽  
Red Light ◽  
Complete Response ◽  
Condyloma Acuminatum ◽  
Recurrence Rates ◽  
Laser Group

To compare the efficacy and safety of CO2 laser plus 5-aminolevulinic acid (ALA) photodynamic therapy (PDT) with CO2 laser for the treatment of multiple condyloma acuminatum (CA), 120 patients with multiple CA were allocated into two groups — combined group ( CO2 laser plus ALA-PDT, n = 60) and CO2 laser group ( CO2 laser plus placebo-PDT, n = 60). After CO2 laser, a 20% ALA or a placebo solution was applied to the CA area 3 h before illumination with red light (635 nm, 100 mW/cm2, 80 J/cm2). The treatment was repeated seven days after the first treatment if the lesions were not completely resolved. The complete response rate, recurrence rate and adverse effects in the two groups were analyzed. After two treatments, the complete response rates in the CO2 laser group and combined group were 100% (509/509) and 100% (507/507) in the CA (p > 0.05), respectively. The recurrence rates in the CO2 laser group and combined group were 44.9% (229/509) and 10.6% (54/507) in the CA (p < 0.05), respectively. The adverse effects in CO2 laser group was more than that in combined group. The combined group is a more effective treatment for multiple CA compared with CO2 laser group. T/S. Style the highlighted text as abstract.

Thalidomide in Multiple Myeloma - A Community Hospital Experience.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 5140-5140 ◽  
Author(s):  
Homayoun Leon Daneschvar ◽  
Hamed Daw ◽  
Asif Chaudhry ◽  
Harris Taylor ◽  
Manmeet Ahluwalia ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Side Effects ◽  
Partial Response ◽  
Community Hospital ◽  
Response Rate ◽  
Complete Response ◽  
M Protein ◽  
Newly Diagnosed ◽  
Number Of Patients

Abstract Multiple Myeloma accounts for 10% of malignant hematologic neoplasms. For the past 30 years, a combination of melphalan and prednisone has been the standard treatment for this disease. Nonetheless, it remains an incurable malignancy with a median survival that does not exceed three years. Recent evidence suggests that angiogenesis is increased in multiple myeloma and has prognostic value. Because of its anti-angiogenic properties, thalidomide has been employed as therapy and several trials show that thalidomide alone is active in 25% to 35% of patients with relapsed and refractory myeloma. Among previously untreated patients with more advanced and symptomatic disease, the combination of thalidomide-dexamethasone doubled the response rate to 72 % (in comparison to thalidomide alone) and induced remissions more rapidly. Objectives: To evaluate the efficacy and side effects of thalidomide in combination with glucocorticoid in previously untreated (newly diagnosed) and treated (refractory to other chemotherapies) multiple myeloma patients in a community hospital setting. Patients and Methods: We retrospectively identified eighty-four consecutive patients with multiple myeloma treated between September 1999 and October 2004 at the Cleveland Clinic Center at Fairview Hospital. The sixteen of eighty-four patients (Table 1) who had received thalidomide were selected for further study. The median starting dose was 150 mg/d. The maintenance dosage was 50–100 mg/d in accordance with tolerability. In addition to thalidomide all sixteen patients were receiving dexamethasone. All provided written informed consent prior to receiving treatment. The primary end point of the study was response rate, defined as complete (undetectable monoclonal M protein in the serum) or partial (greater than 50% reduction in serum monoclonal M protein level) Results: Three patients achieved a partial response in the refractory group and 2 in the newly diagnosed group. One patient achieved a complete response in the refractory group and four in newly diagnosed patients. Sixty percent of the patients in the refractory group and 100% of the newly diagnosed patients survived the follow up time (Table 2). Major side effects included sedation in four (25%), deep venous thrombosis in three (18.7%), neuropathy in three (18.7%) and constipation in two (12.5 %) of the patients. Conclusion: The combination of thalidomide and dexamethasone appears to show promising activity in patients with newly diagnosed and possibly with refractory MM. The combination induced a high frequency of response, rapid onset of remission, and low incidence of serious irreversible toxicity. However, ongoing randomized trials are still needed to define further the role of thalidomide with dexamethasone in the treatment of multiple myeloma. Table 1 Patients Characteristics Refractory patients Newly diagnosed patients Number of patients 10 6 Age (years) 66.3 60.5 Sex 7 male, 3 female 1 male, 5 female IgA type 3 3 IgG type 6 2 Biclonal 1 1 Table 2 Refractory patients Newly diagnosed patients Partial response 3 2 Complete response 1 4 No response 6 0 Median follow up (months) 25.2 11.3 Median progression free survival (months) 7.5 10 Diagnosis to start of thalidomide (months) 18.7 2.5 Time on thalidomide (months) 14.2 11.2 Number of deaths (during follow up time) 4 0

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