Complete Response Rate In Group Research Articles

Efficacy and safety of low dose Mycophenolate mofetil treatment for immunoglobulin G4-related disease: a randomized clinical trial.

This randomized, controlled clinical trial aims to compare the efficacy and safety of glucocorticoid combined with MMF and glucocorticoid monotherapy for patients with IgG4-related disease. Sixty-nine patients newly diagnosed with IgG4-related disease were randomly divided into two groups (35 patients in Group I and 34 patients in Group II). Patients in Group I received glucocorticoid monotherapy (0.6-0.8 mg/(kg·day) and tapered gradually); patients in Group II received glucocorticoid combined with MMF therapy (1-1.5 g/day). All the patients were followed up at 1, 3, 6 and 12 months. The primary endpoint was response rate in 12 months and the secondary endpoints were relapse, remission rate and adverse reactions. Group I and Group II shared almost the same efficacy at the 1 month treatment, but during the follow-up, the complete response rate in Group II was much higher than that in Group I at different time points, and the cumulative relapse rate during 1 year of therapy was much higher in Group I than that in Group II (40.00 vs 20.59%). The remission rate was lower in Group I (51.42 vs 76.47%). Relapses were more likely to happen in lung, lacrimal gland, salivary gland, paranasal sinus and kidney. MMF could reduce relapse, especially organs recurrence. No serious adverse reactions occurred in the two groups. Combination treatment with glucocorticoid and MMF was more effective than the monotherapy, and the relapse of IgG4-related disease might be associated with the elevated levels of serum IgG4 and the low glucocorticoid maintenance dose. ClinicalTrials.gov, www.clinicaltrials.gov, NCT02458196.

Long-course oxaliplatin-based preoperative chemoradiation versus 5 × 5 Gy and consolidation chemotherapy for cT4 or fixed cT3 rectal cancer: results of a randomized phase III study

Improvements in local control are required when using preoperative chemoradiation for cT4 or advanced cT3 rectal cancer. There is therefore a need to explore more effective schedules. Patients with fixed cT3 or cT4 cancer were randomized either to 5 × 5 Gy and three cycles of FOLFOX4 (group A) or to 50.4 Gy in 28 fractions combined with two 5-day cycles of bolus 5-Fu 325 mg/m(2)/day and leucovorin 20 mg/m(2)/day during the first and fifth week of irradiation along with five infusions of oxaliplatin 50 mg/m(2) once weekly (group B). The protocol was amended in 2012 to allow oxaliplatin to be then foregone in both groups. Of 541 entered patients, 515 were eligible for analysis; 261 in group A and 254 in group B. Preoperative treatment acute toxicity was lower in group A than group B, P = 0.006; any toxicity being, respectively, 75% versus 83%, grade III-IV 23% versus 21% and toxic deaths 1% versus 3%. R0 resection rates (primary end point) and pathological complete response rates in groups A and B were, respectively, 77% versus 71%, P = 0.07, and 16% versus 12%, P = 0.17. The median follow-up was 35 months. At 3 years, the rates of overall survival and disease-free survival in groups A and B were, respectively, 73% versus 65%, P = 0.046, and 53% versus 52%, P = 0.85, together with the cumulative incidence of local failure and distant metastases being, respectively, 22% versus 21%, P = 0.82, and 30% versus 27%, P = 0.26. Postoperative and late complications rates in group A and group B were, respectively, 29% versus 25%, P = 0.18, and 20% versus 22%, P = 0.54. No differences were observed in local efficacy between 5 × 5 Gy with consolidation chemotherapy and long-course chemoradiation. Nevertheless, an improved overall survival and lower acute toxicity favours the 5 × 5 Gy schedule with consolidation chemotherapy. The trial is registered as ClinicalTrials.gov number NCT00833131.

A randomized phase 2 trial of a preparative regimen of bortezomib, high‐dose melphalan, arsenic trioxide, and ascorbic acid

Bortezomib is active for newly diagnosed and relapsed multiple myeloma, and it has synergistic activity with melphalan. The authors of this report conducted a randomized trial to determine the safety and efficacy of adding bortezomib to a preparative regimen of arsenic trioxide (ATO), ascorbic acid (AA), and melphalan. Among 60 patients who enrolled between October 2006 and September 2007, 58 patients underwent autologous transplantation with a preparative regimen of melphalan 200 mg/m(2) intravenously, AA 1000 mg daily intravenously for 7 days, and ATO 0.25 mg/kg intravenously for 7 days. Patients were randomized to receive no bortezomib (Group 1), bortezomib 1 mg/m(2) × 3 doses (Group 2), and bortezomib 1.5 mg/m(2) × 3 doses (Group 3). Primary endpoints were complete response (CR), grade IV toxicity, and 90-day treatment-related mortality (TRM). Secondary endpoints were progression-free survival (PFS) and overall survival (OS). The median follow-up of all surviving patients was 36 months (range, 20-43 months). The CR rates in Groups 1, 2, and 3 were 20%, 10%, and 10%, respectively. Grade 3 and 4 nonhematologic toxicities and TRM were comparable. The median OS was not reached in the groups, whereas the median PFS in Groups 1, 2, and 3 was 17.8 months, 17.4 months, and 20.7 months, respectively. PFS and OS were significantly shorter in patients who had high-risk cytogenetics (P = .016 and P = .0001, respectively) and relapsed disease (P = .0001 and P = .0001, respectively) regardless of the treatment group. Adding bortezomib to a preparative regimen of ATO, AA, and high-dose melphalan was safe and well tolerated in patients with multiple myeloma. There was no significant improvement in the CR rate, PFS, or OS in the bortezomib groups.

Efficacy according to Dexamethasone Dose in Combination with Aprepitant and Granisetron during Cisplatin-based Chemotherapy

The purpose of this study was to evaluate the dosage of dexamethasone in combination with granisetron and aprepitant when used for the prevention of acute and delayed nausea and vomiting in patients receiving high-dose cisplatin chemotherapy. The study was retrospective. Ninety-two patients received cisplatin (≥50 mg/m 2 ) and either a high-dose (Group I, n=57) or low-dose (Group II, n=35) regimen of dexamethasone. The high-dose regimen consisted of intravenous administration of 20 mg on day 1 and 8 mg on days 2∼4. The low-dose regimen consisted of intravenous administration of 10 mg before cisplatin and oral dexamethasone 4 mg on days 2∼4. Both groups received granisetron and aprepitant. The primary endpoint was complete response over 5 days following cisplatin administration. In the acute phase, complete response occurred in 87.7% of Group I and 91.4% of Group II patients (p=0.58). In the delayed phase, the proportions of patients without emesis in Groups I and II were 84.2% and 65.7%, respectively (p=0.04). In the overall phase, the complete response rates in Groups I and II were 80.7% and 65.7%, respectively (p=0.11). The high-dose dexamethasone regimen is superior to the low-dose in preventing delayed chemotherapy-induced nausea and vomiting, with no significant differences evident in the acute and overall phases. The high-dose dexamethasone regimen should be considered as a standard antiemetic therapy for cisplatin-treated patients.

Efficacy of IFN therapy based on duration period of negative HCV-RNA during IFN administration

We assessed the relationship between the duration period of negative hepatitis C virus (HCV)-RNA during interferon (IFN) therapy and the efficacy after prolonged IFN therapy in patients with HCV-genotype 1b and high virus load of more than 1 mega equivalents/ml (Meq/ml) retrospectively. A total of 100 patients who had HCV-genotype 1b and a high virus load of more than 1 Meq/ml and were treated with natural IFN-α for more than 12 months were enrolled in this trial. These patients were given 6 MU of IFN daily for 8 weeks, followed by three times weekly for another more than 44 weeks. The HCV-RNA pattern during IFN therapy according to negative or positive of the serum HCV-RNA by reverse transcription nested polymerase chain reaction (RT-nested PCR) from 2 months after the initiation of IFN to the termination of IFN were classified as follows: group 1: constant negative HCV-RNA ( n=41 cases), group 2: constant positive HCV-RNA ( n=35 cases), group 3: HCV-RNA pattern except for group 1 or group 2 ( n=24 cases). A complete response (CR) was defined as negative HCV-RNA by RT-nested PCR at two points, 3 and 6 months after the completion of IFN therapy. CR rate was 58.5% (24 cases) in group 1, but CR rate in group 2 or group 3 was 0%. In group 1, the CR rate was 100% (10/10) in patients with negative HCV-RNA constantly for period of more than 24 months during IFN therapy. On the other hand, all patients who had positive HCV-RNA 2 months after the initiation of IFN did not get CR. In conclusion, it seems to us that the attainment of constantly negative HCV-RNA for the period of more than 24 months during IFN therapy is highly related to CR.

Effective administration methods and dosages of interferon therapy for chronic hepatitis C

The efficacy of interferon alfa (IFN-α) was evaluated in 127 hepatitis C virus—ribonucleic acid (HCV-RNA)—positive patients with chronic hepatitis C in relation to HCV-RNA levels and genotype. Patients were assigned to one of three groups. Patients in group A received IFN-α daily for 8 weeks (total dose, 336 million units [MU]); patients in group B received IFN-α daily for 4 weeks and then intermittently for 20 weeks (total dose, 348 MU); and patients in group C received IFN-α daily for 2 weeks and then intermittently for 22 weeks (total dose, 480 MU). Complete response rates in groups B and C were significantly higher than those in group A, regardless of the virus level or genotype. Complete response rates in groups B and C were similar, but in patients with a high virus level or HCV-RNA genotype II, the partial response rate in group C was significantly higher than that in group B. In conclusion, IFN-α was more effective after daily and then intermittent administration after daily administration only, and a higher daily dose was necessary to be more effective in patients with high virus levels or HCV-RNA genotype II.

Therapeutic guidelines and results in advanced seminoma.

Twenty patients with advanced seminoma were treated with chemotherapy. Fourteen patients were previously untreated (group 1) and received vinblastine, bleomycin, and cisplatin (VPB) at presentation. Six patients had received prior radiation therapy (group 2), and at relapse received either VPB or VP-16-213 (etoposide)-cisplatin. Within group 1, five patients received no further therapy after VPB (group 1A), six patients received radiation to residual radiographic abnormalities (group 1B), and three patients underwent surgery to remove residual radiographic areas following VPB (group 1C). The complete response rate in group 1 was 14/14 (100%). At present within group 1A, 5/5 patients (100%) are alive and disease-free (NED) for a median follow-up of 32 + months. In group 1B, 6/6 patients (100%) are alive and NED for a median follow-up of 17+ months. In group 1C, 3/3 patients (100%) had residual fibrosis at the time of surgical resection. Two of these patients died of postoperative complications with no evidence of disease and the third is alive and NED at 19+ months. In group 2, 4/6 patients (67%) achieved a complete remission, including two patients who are NED at 22+ and 85+ months, respectively. Two have died and two are alive with progressive disease. Doses of chemotherapy to group 2 patients were substantially lower than the doses given to group 1 patients. We conclude that chemotherapy is acceptable initial therapy for advanced seminoma, and prior extensive radiation therapy may impair the ability to give adequate doses of chemotherapy in patients who relapse. Residual masses after chemotherapy are often fibrotic and the role of postchemotherapy radiation therapy in these patients is uncertain.

Acute lymphoblastic leukemia: end-result analysis of treatment and prognostic factors in Indian patients.

Acute Lymphatic Leukemia (ALL) patients seen during the period 1974-1978 at the Tata Memorial Hospital. Bombay, are analyzed retrospectively to evaluate the clinical features at presentation, results of sequential therapy, and prognostic factors. A total of 301 patients were registered during the study period. There were 153 evaluable patients. Of these 73 patients received induction therapy with vincristine and prednisolone (VP) followed by cranial prophylaxis (cranial radiotherapy, 2,400 rads, and 10 weekly intrathecal injections of methotrexate 7.5 mg/m20 and continuous oral maintenance with daily 6-mercaptopurine and weekly methotrexate (group A). Another 39 patients (group B) received pulse therapy with vincristine and prednisolone during maintenance therapy. Finally 41 patients (group C) received L-asparaginase during induction and pulse therapy in addition to drugs as in group A. Of the 153 patients, 88 (58%) achieved complete response after induction treatment. Induction remission was 53% with vincristine and prednisolone (group A and group B), whereas it was 70% in group C. The difference in complete response rate in group C was statistically significant (P less than 0.05). The 3-year survival in our series was 22%, with median survival of 11 months. Group C patients receiving L-asparaginase along with vincristine and prednisolone showed 41% 3-year survival compared to 16% for group B. The 3-year survival in group A patients was only 7%, probably owing to lack of pulse therapy during maintenance treatment. The prognostic factors such as age, sex, WBC count, and mediastinal node were compared for induction remission and total survival. Possible factors relating to poor results in our series as compared to developed countries are discussed.