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Single-arm Study (single-arm + study)
Selected AbstractsSalvage treatment for persistent and recurrent T1,2 nasopharyngeal carcinoma by stereotactic radiosurgeryHEAD & NECK: JOURNAL FOR THE SCIENCES & SPECIALTIES OF THE HEAD AND NECK, Issue 9 2001Daniel T. T. Chua FRCR Abstract Objective To study the efficacy of stereotactic radiosurgery in salvaging early-stage persistent and recurrent nasopharyngeal carcinoma (NPC) after primary radiotherapy. Methods A prospective single-arm study evaluating the response and outcome of patients with rT1,2 NPC treated by stereotactic radiosurgery. Eleven patients with rT1,2 were treated by radiosurgery between March 1998 and March 2000. Four patients were treated for persistent disease occurring within 4 months after primary radiotherapy, six were treated for first recurrence, and one for third recurrence. Six patients had rT1 disease and five had rT2 disease. Most patients had disease not amenable to brachytherapy, surgery, or external re-irradiation. The median target volume was 5.8 cc (range, 3.3,16.9). Radiosurgery was performed with multiple noncoplanar arcs of photon, with a median dose of 12.5 Gy delivered to the 80% isodose line (range, 12,14 Gy). Median follow-up time after radiosurgery was 18 months (range, 9,30). Results Nine patients had complete regression of tumor as assessed by imaging, nasopharyngoscopy, and biopsy; one patient had partial regression of tumor; whereas one patient had static disease. The overall response rate was 91% (10 of 11) and the complete response rate was 82% (9 of 11). Two patients with complete response subsequently had local relapse develop, with one recurrence outside the treated volume 8 months after radiosurgery, and the other within the treated volume 6 months after radiosurgery. One patient with a partial response had neck node recurrence develop. Temporal lobe necrosis occurred in one patient but probably represents sequelae of primary radiation after reviewing the dosimetry. Ten patients are still alive, whereas one patient with local relapse had distant metastases develop and died. The estimated 1-year local control rate after radiosurgery was 82%. Conclusions Our preliminary results indicate that stereotactic radiosurgery is an effective treatment modality for persistent and recurrent T1,T2 NPC, and early control rate seems to be comparable to other salvage treatments. More clinical experiences and longer follow-up are still needed to validate our results and to address fully the role of radiosurgery in salvaging local failures of NPC. © 2001 John Wiley & Sons, Inc. Head Neck 23: 791,798, 2001. [source] An open-label, phase 2 trial of denosumab in the treatment of relapsed or plateau-phase multiple myeloma,,AMERICAN JOURNAL OF HEMATOLOGY, Issue 10 2009Ravi Vij RANKL is a key mediator of osteoclast differentiation, activation, and survival. Preclinical data suggest that aberrant production and activation of osteoclasts may influence proliferation of multiple myeloma (MM) cells in the bone marrow. Reports have also shown that inhibiting RANKL may have a direct effect on RANK-expressing myeloma cells and a therapeutic role in treating the disease. In mouse myeloma models, inhibition of RANKL led to reduced serum paraprotein levels and tumor burden. Based on this hypothesis, this proof-of-concept, single-arm study investigated whether RANKL inhibition with denosumab could reduce serum M-protein levels in relapsed or plateau-phase myeloma subjects. All subjects received denosumab monthly, with loading doses on days 8 and 15 of month one, until disease progression or subject discontinuation. Results of this ongoing study demonstrated that no subjects in either cohort met the protocol-defined objective response criteria of complete response (CR) or partial response (PR), but that denosumab effectively inhibited the RANKL pathway regardless of previous exposure to bisphosphonates, as evidenced by suppressed levels of the bone turnover marker, serum C-terminal telopeptide of type 1 collagen (sCTx). Eleven (21%) subjects who relapsed within 3 months before study entry maintained stable disease for up to 16.5 months. Nineteen (46%) subjects with plateau-phase myeloma maintained stable disease for up to 18.3 months. The adverse event (AE) profile for denosumab and its dosing schedule in these populations was consistent with that for advanced cancer patients receiving systemic therapy. Additional controlled clinical studies of denosumab in subjects with both relapsed and plateau-phase MM are warranted. Am. J. Hematol. 2009. © 2009 Wiley-Liss, Inc. [source] Benefits of conversion from mycophenolate mofetil to enteric-coated mycophenolate sodium in pediatric renal transplant patients with stable graft functionPEDIATRIC TRANSPLANTATION, Issue 2 2009Rejane De Paula Meneses Abstract:, Conversion from MMF to EC-MPS may reduce GI complications and permit increased MPA dosing with a concomitant reduction in CNI dose. In a prospective trial, paediatric renal transplant patients with stable graft function were converted from MMF to EC-MPS and followed-up for 12 months. Data from 28 patients (mean age 13.9 ± 3.1 yr) were available for analysis. Mean EC-MPS dose increased significantly from conversion to month 12 (668 ± 81 mg/m2/day vs. 747 ± 98 mg/m2/day, p < 0.001). CsA-ME dose (n = 23) decreased from 5.3 ± 1.7 mg/kg/day at conversion to 4.6 ± 1.4 mg/kg/day at month 12 (p = 0.010). cGFR increased from 69.5 ± 23.3 mL/min/1.73 m2 at the time of conversion to 80.7 ± 30.7 mL/min/1.73 m2 at month 12 (p = 0.007). The number of patients reporting at least one GI event during six months prior to conversion was 15/28 (53.6%), declining to 8/28 (28.6%) at month 6 post-conversion and 5/28 (17.8%) at month 12. This single-arm study suggests that conversion of paediatric renal transplant patients from MMF to EC-MPS does not compromise efficacy and leads to improved GI tolerability. MPA dose increased and CsA-ME dose decreased significantly, with an associated improvement in calculated GFR. A large-scale controlled trial is required to confirm these promising findings. [source] Selective neck dissection and deintensified postoperative radiation and chemotherapy for oropharyngeal cancer: A subset analysis of the university of pennsylvania transoral robotic surgery trial,THE LARYNGOSCOPE, Issue 9 2010Gregory S. Weinstein MD Abstract Objectives/Hypothesis: The purpose of this study was to determine the regional recurrence rate of node-positive oropharyngeal squamous cell carcinoma (OPSCC) in patients undergoing transoral robotic surgery (TORS) and selective neck dissection (SND) followed by observation, radiation, or concurrent chemoradiation. Study Design: A prospective, phase I, single-arm study was conducted. All OPSCC patients who voluntarily participated in a surgical trial with TORS and SND at an academic tertiary referral center from May 2005 to July 2007 were included. Methods: Thirty-one patients with previously untreated OPSCC undergoing TORS and SND (29 unilateral and two bilateral) were included. There were 29 males and two females, with ages ranging from 36 to 76 years (median = 55 years) with one palate, one lateral wall, 17 tonsil, 11 base of tongue, and one vallecula primary tumor classified as follows: T1 (n = 9, 29%), T2 (n = 15, 48.4%), T3 (n = 7, 22.6%), N0 (n = 6, 19.4%), N1 (n = 15, 48.4%), N2b (n = 10, 32.3%), and N2c (n = 1, 3.2%). There were three stage I (9.7%), two stage II (6.5%), 15 stage III (48.4%) and 11 stage IVa (35.5%) patients. Twenty-two patients were treated postoperatively with adjuvant therapy (12 radiation alone and 12 combined radiation and chemotherapy). Primary outcome measured was regional recurrence rate. Results: There was one regional recurrence on the contralateral, non-operated neck and one distant recurrence among the 31 patients who underwent SND. Conclusions: SND after TORS resection of primary OPSCC enables the use of selective and deintensified adjuvant therapy to reduce regional recurrence rates. Laryngoscope, 2010 [source] A prospective study of concurrent cyclophosphamide/methotrexate/5-fluorouracil and reduced-dose radiotherapy in patients with early-stage breast carcinomaCANCER, Issue 7 2004Jennifer R. Bellon M.D. Abstract BACKGROUND Concurrent administration of chemotherapy and radiotherapy has the potential advantage of delaying neither treatment and providing radiation sensitization. However, the optimal approach to concurrent treatment in women with early-stage breast carcinoma remains undefined. We present updated results of a prospective protocol of concurrent cyclophosphamide/methotrexate/5-fluorouracil (CMF) and reduced-dose radiotherapy, focusing on tumor control and patient tolerance. METHODS One hundred twelve women with AJCC Stage I or Stage II breast carcinoma with 0,3 positive axillary lymph nodes were enrolled in a prospective single-arm study of concurrent CMF and reduced-dose radiotherapy (39.6 gray [Gy] to the whole breast, 16-Gy boost). A high proportion of women had risk factors associated with an increased risk of local disease recurrence, including age < 40 (32%), close or positive margins (37%), or lymphatic/vascular invasion (51%). The median follow-up period was 94 months. RESULTS The 5-year overall survival rate was 94%. By 60 months, 5 patients (4%) experienced local disease recurrence and 19 patients (17%) experienced distant metastasis. There were no isolated regional lymph node recurrences. Local disease recurrence occurred in 1 of 25 patients (4%), 1 of 16 patients (6%), and 3 of 70 patients (4%) with positive, close (< 1 mm), and negative margins, respectively. One patient developed acute myelogenous leukemia. An additional patient developed Grade 2 pneumonitis. Cosmetic results were not recorded uniformly for all patients and therefore could not be reliably analyzed. CONCLUSIONS Concurrent CMF and reduced-dose radiotherapy resulted in a low level of late toxicity and excellent local tumor control, despite the large proportion of patients with substantial risk factors for local disease recurrence. Future studies of concurrent regimens, particularly in patients at high risk of local disease recurrence, are warranted. Cancer 2004;100:1358,64. © 2004 American Cancer Society. [source] | ||||||||||