Complete responder

The Phase I studies of vindesine determined the maximum tolerated dose of the compound to be 3-4 mg/m (body surface area) when given once weekly (i.v.) 78). Mild leukopenia ensues, reaching a nadir after about 4 days, and is accompanied by neurotoxicity. Several patients responded to drug treatment during this initial trial, including several complete responders with acute leukemias and partial responders with malignant melanoma and non-Hodgkin s lymphoma. Subsequent studies indicated that vindesine was active in vincristine-resistant childhood lymphocytic leukemia and, when combined with cisplatin, was effective in... 

Kies MS, Mira JG, Crowley JJ, etal. Multimodal therapy for limited small-cell lung cancer A randomized study of induction combination chemotherapy with or without thoracic radiation in complete responders, and with wide-field vs reduced-field radiation in partial responders A Southwest Oncology Group Study. J Clin Oncol 1987 5 592-600. 

Lebeau B, Chastang C, Brechot JM, et al. A randomized trial of delayed thoracic radiotherapy in complete responder patients with small-cell lung cancer Petites Cellules Group. Chest 1993 104 726-733. 

In 1993, investigators at the Massachusetts General Hospital (MGH) published the results of an institutional study, which became the model for several subsequent trials (67). In this first report, 53 patients (T2-4, NXMO) underwent maximal TURBT, followed by two cycles of CMV, then 4000 cGy + two cycles of single-agent cisplatin. Patients then underwent endoscopic reevaluation and those who had an incomplete response to therapy and who were surgical candidates underwent cystectomy, whereas complete responders were consolidated with an additional 2480 cGy and one additional cycle of cisplatin. Following 11 dropouts, 42 patients completed therapy and there was... 

Muderspach et al. (31) reported the results of a pilot study of concurrent carboplatin (30 mg/m2 twice weekly) with radiation in 22 patients with stage IIA (>4 cm) to IIIB disease. The most significant chemotherapy-related side effects were grade 3 neutropenia and anemia. The authors reported 19 complete responders to this regimen, although only 11 patients were alive and disease-free at the time of their report. Because cisplatin... 

Small cell lung cancer (SCLC) includes approximately 20-25% of all cases of lung cancer seen worldwide. SCLC differs from other types of lung cancer in its more aggressive course and its superior responsiveness to chemotherapy and radiotherapy. The main modality of treatment for SCLC is combination chemotherapy. Eor patients with limited disease achieving a major response on chemotherapy, this is usually combined with concurrent thoracic irradiation. Prophylactic whole brain irradiation is often administered to complete responders because of the high probability of CNS relapse with associated morbidity. 

Maj M, Pirozzi R, Kemah D Long-term outcome of lithium prophylaxis in patients initially classified as complete responders. Psychopharmacol Bull 98 535-538, 1989... 

GBM 15 Doxorubicin + radiation IV Doxorubicin days 1,21 radiation days 1-21,21-23 4/10 Patients completely responded... 

In an analysis of data from 270 patients with metastatic melanoma in eight clinical trials, high-dose aldesleukin (8.4-9.8 MU/kg during each cycle) produced an overall objective response rate of 16%, with 17 complete responses and 26 partial responses (12). Although the response rate was low, there was a durable response for at least 24 months in 10 of 17 complete responders. Adverse effects were primarily the same as those previously described in patients with metastatic renal cell carcinoma, and severe hypotension (64%) was the most frequent. Six patients died from bacterial sepsis, but none was taking prophylactic antibiotics. 

Of the 255 patients used for the revised application, 28 (11 percent) were classified as partial responders, meaning that their tumors had shrunk by half or more, and existing lesions had not expanded in size. FDA officials were convinced by this measure of Proleukin s efficacy. They even reproduced Chiron s data in their Summary for Basis of Approval Seven of the 28 partial responders and none of the complete responders were symptomatic from their disease (PS=i) at study entry. Of these seven patients, one returned to baseline after therapy and the other six became asymptomatic (PS=o). 18 Between the ECOG status and uncertainties in how to define partial and "complete responses, proof of efficacy, now more than ever, required patient assessment and communication between physicians and patients in the clinical trial. Furthermore, the company and FDA officials had to negotiate appropriate measures of efficacy and how to scale data from various tests. 

About 40% of patients with OCD do not completely respond to adequate trials of SSRIs. Hence, augmentation strategies are necessary for SSRI partial and non-responders. As mentioned above, up to 65-70% of patients with OCD have a clinically meaningful response to their first SSRI therapy. Moreover, with... 

LA. Infusion. In 1961, Byron et al. reported on their experience with intraarterial infusion of ten patients with bladder cancer who failed to respond. The use of intraarterial chemotherapy was reported by Nevin and Hoffman (1975), who surgically implanted catheters into each internal iliac artery. 5-Fluoroura-cil was infused for 10 days and then every other week for 3 months when it was given as an adjunct to chemotherapy. Regression of local disease was seen in six of ten patients. A mean survival time of 25 months was noted in the complete responders. Fourteen of 28 patients responded but, because of the dosage and myelosuppression, local irritation was significant. 

Inoue Y et al. (1994) Hypervascular liver metastases of gastric cancer completely responding to transcatheter oily chemoembolization using epirubicin hydrochloride, mitomycin C and lipiodol. Gan To Kagaku Ryoho 21 1665-1667... 

Results with 102 patients indicated biopsy-proven complete response in 79% of patients (initial followup) with more than half continuing to be complete responders, often more than 2 years posttreatment. The median survival was 3.5 years, and disease-specific survival was 5.7 years. In a smaller segment of this trial population with microinvasive lung cancer (the actual approved indication), 62 inoperable patients were treated, 11 of whom were considered not to be candidates for surgery or radiation therapy. Indicated in Table 147.4 are the outcomes in this group. - ... 

Overholt etal. reported on 100 patients treated for this indication with Photofrin and the balloon light emitter. Fifty-six of 73 patients with HGD were complete responders, and 32 had complete elimination of the Barrett s. ... 

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