Subject(s)
Gastrointestinal Neoplasms , Gastrointestinal Stromal Tumors , Sarcoma , Follow-Up Studies , Gastrointestinal Neoplasms/diagnosis , Gastrointestinal Neoplasms/epidemiology , Gastrointestinal Neoplasms/therapy , Gastrointestinal Stromal Tumors/diagnosis , Gastrointestinal Stromal Tumors/epidemiology , Gastrointestinal Stromal Tumors/therapy , Humans , Sarcoma/therapySubject(s)
Bone Neoplasms/therapy , Medical Oncology/standards , Osteosarcoma/therapy , Patient Participation , Adult , Aftercare/methods , Aftercare/standards , Age Factors , Antineoplastic Combined Chemotherapy Protocols/standards , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Biopsy , Bone Neoplasms/diagnosis , Bone Neoplasms/epidemiology , Bone Neoplasms/pathology , Bone and Bones/diagnostic imaging , Bone and Bones/pathology , Bone and Bones/surgery , Child , Europe , Humans , Incidence , Long-Term Care/methods , Long-Term Care/standards , Magnetic Resonance Imaging , Medical Oncology/methods , Neoadjuvant Therapy/methods , Neoadjuvant Therapy/standards , Neoplasm Staging , Orthopedic Procedures/methods , Orthopedic Procedures/standards , Osteosarcoma/diagnosis , Osteosarcoma/epidemiology , Osteosarcoma/pathology , Positron Emission Tomography Computed Tomography , Radionuclide Imaging , Radiotherapy, Adjuvant/methods , Radiotherapy, Adjuvant/standards , Self-Help Groups/standards , Societies, Medical/standards , Survivorship , Treatment OutcomeSubject(s)
Medical Oncology/standards , Patient Participation , Sarcoma/therapy , Adult , Aftercare/methods , Aftercare/standards , Antineoplastic Combined Chemotherapy Protocols/standards , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Biopsy , Europe , Humans , Incidence , Lymphatic Metastasis/diagnostic imaging , Lymphatic Metastasis/pathology , Magnetic Resonance Imaging/methods , Magnetic Resonance Imaging/standards , Medical Oncology/methods , Neoadjuvant Therapy/methods , Neoadjuvant Therapy/standards , Neoplasm Grading , Neoplasm Staging , Radiotherapy, Adjuvant/methods , Radiotherapy, Adjuvant/standards , Sarcoma/diagnosis , Sarcoma/epidemiology , Sarcoma/pathology , Self-Help Groups/standards , Societies, Medical/standards , Surgical Procedures, Operative/methods , Surgical Procedures, Operative/standards , Tomography, X-Ray Computed/methods , Tomography, X-Ray Computed/standards , Treatment OutcomeSubject(s)
Gastrointestinal Stromal Tumors/therapy , Medical Oncology/standards , Patient Participation , Adult , Aftercare/methods , Aftercare/standards , Antineoplastic Combined Chemotherapy Protocols/standards , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Chemotherapy, Adjuvant/methods , Chemotherapy, Adjuvant/standards , Digestive System Surgical Procedures/methods , Digestive System Surgical Procedures/standards , Endosonography , Europe , Gastrointestinal Stromal Tumors/diagnosis , Gastrointestinal Stromal Tumors/epidemiology , Gastrointestinal Stromal Tumors/pathology , Humans , Image-Guided Biopsy/methods , Image-Guided Biopsy/standards , Incidence , Intestines/diagnostic imaging , Intestines/pathology , Intestines/surgery , Laparoscopy/methods , Laparoscopy/standards , Margins of Excision , Medical Oncology/methods , Neoplasm Staging , Self-Help Groups/standards , Societies, Medical/standards , Stomach/diagnostic imaging , Stomach/pathology , Stomach/surgery , Tomography, X-Ray Computed , Treatment OutcomeABSTRACT
PURPOSE: Immunotherapy (IL-2 and INF-α) was the treatment of choice for advanced renal cell carcinoma (RCC) until antiangiogenic therapy with tyrosin kinase inhibitors was developed in the early 2000s. This clinical trial explored the efficacy and toxicity of sequential treatment of IL-2 plus INF-α followed by sorafenib. METHODS: Eligibility criteria included measurable, non-resectable, histologically confirmed predominantly clear cell RCC, no prior systemic treatment, and ECOG PS 0-2. The treatment regimen was a 6-week cycle of subcutaneous IL-2 at 9 × 10(6) IU on days 1-6 of weeks 1, 2, 4 and 5 plus s.c. INF-α at 6 × 10(6) IU on days 1, 3 and 5 of weeks 1-6. Responders received 6 additional weeks of this regimen. All patients received oral sorafenib (400 mg bid) after immunotherapy until disease progression. The primary endpoint was progression-free survival. RESULTS: Forty-one patients were enrolled, median age 57 years. ECOG was 0/1 in 17/20 patients, 35 patients had prior nephrectomy and 18 patients pure clear cell cancer. Median PFS was 7.4 months (95 % CI 6.5-13.1) and OS was 16.6 months (95 % CI not reached). In 36 patients evaluable for response, ORR was 44.4 % and control rate was 94.4 %. Most adverse events (AEs) were Grade 1 or 2 toxicities (84.7 %). During immunotherapy the most common AEs were pyrexia (82.9 %), asthenia (56.1 %) and anorexia (46.3 %), whereas during sorafenib were diarrhoea (48.8 %) and hand-foot syndrome (46.3 %). CONCLUSIONS: A sequential regimen of IL-2 and INF-α followed by sorafenib showed effectiveness and manageable toxicity in patients with advanced RCC.
Subject(s)
Carcinoma, Renal Cell/drug therapy , Interferon-alpha/administration & dosage , Interleukin-2/administration & dosage , Kidney Neoplasms/drug therapy , Niacinamide/analogs & derivatives , Phenylurea Compounds/administration & dosage , Protein Kinase Inhibitors/administration & dosage , Adult , Aged , Aged, 80 and over , Carcinoma, Renal Cell/therapy , Combined Modality Therapy/methods , Disease Progression , Disease-Free Survival , Female , Humans , Immunotherapy/methods , Kidney Neoplasms/therapy , Male , Middle Aged , Neoplasm Metastasis , Niacinamide/administration & dosage , Probability , Sorafenib , Time Factors , Treatment OutcomeABSTRACT
AIM: The aim of this study was to evaluate the utility of positron emission tomography with 18F-fluorodeoxyglucose (FDG-PET) in monitoring response in refractory GIST. METHODS: This multicenter study prospectively evaluated 21 patients with locally advanced and/or metastatic GIST refractory to with high-dose imatinib (800 mg/day) treated with doxorubicin 15-20 mg/m2/weekly for 4 cycles, followed by imatinib maintenance (400 mg/day). CT and FDG-PET were performed at baseline and after completion of therapy. RESULTS: Mean baseline tumor size on CT was 5.9 cm. Median progression-free survival (PFS) was 219 days (range 62-1108). Three out of 21 patients (14%) had partial responses (PR) under RECIST criteria, 12 patients (57%) remained stable (SD) and 6 showed progression (PD) of the disease during treatment (29%). Six patients had PR by FDG-PET, 15 showed SD (n=9) or PD (n=6) based on EORTC criteria. Patients with a PFS <6 mo showed a significantly higher ∑SUVmax at baseline (26.04±13.4) than those with PFS≥6 mo (9.82±5.0) (P<0.05). A correlation was found between PET response and PFS: PR 14±6.1 mo, SD 5.5±0.8 mo and PD 3.5±4.1 mo (P<0.05). A residual SUVmax <5 after treatment correlated with improved PFS (314±315 days vs 131±91 days) (P<0.01). Survival curves showed a significant association between PET response and PFS (P<0.05). Patients with wild-type genotype KIT (KIT-WT) showed a significantly lower baseline SUVmax (5.36±1.4) than non-WT KIT (8.40±3.6) (P<0.05). CONCLUSION: FDG-PET is useful in assessing response of GIST refractory to imatinib and correlates with the presence of KIT-WT. Baseline ∑SUVmax can predict response to treatment in this series.