Vacuna terapéutica racotumomab en un anciano con cáncer avanzado de pulmón / Racotumomab therapeutic vaccine in an elderly with advanced lung cancer

Se presenta el caso clínico de un anciano de 84 años de edad, fumador, con diagnóstico de cáncer de pulmón en etapa IV, quien fue incluido en el ensayo clínico de fase III para ser tratado con racotumumab. Se observó mejoría clínica y del estado general del paciente, pues según la escala funcional concluyó el estudio con ECOG 0. Por tanto, es oportuno destacar que esta vacuna incrementa la supervivencia de los afectados por cáncer de pulmón de células no pequeñas recurrentes o en estadios avanzados.

The case report of a 84 years elderly smoker, is presented with diagnosis of lung cancer in stage IV who was included in the phase III clinical trial to be treated with racotumomab. Clinical improvement and recovery of the patient's general state was observed, because according to the functional scale the study concluded with ECOG 0. Therefore, it is opportune to highlight that this vaccine increases the survival of those affected by recurrent non-small cells lung cancer or in advanced stages.

Revaprazan (Revanex(R)), a Novel Acid Pump Antagonist, for Duodenal Ulcer: Results of a Double-Blind, Randomized, Parallel, Multi-Center Phase III Clinical Trial / 대한소화기내시경학회지

BACKGROUND/AIMS: To assess the comparative efficacy and safety of revaprazan, a novel acid pump antagonist, versus omeprazole in patients with duodenal ulcer, we performed a randomized, double-blind, phase III, multicenter trial. METHODS: Two hundred and twenty eight patients were randomized to 4 weeks of treatment with either revaprazan 200 mg or omeprazole 20 mg once daily. Primary efficacy parameter was complete ulcer healing by endoscopy, and secondary parameter was the improvement in the severity of daytime and nighttime pain. RESULTS: Healing rates at 4 weeks (intention-to-treat analysis) were 91.7% with revaprazan 200 mg and 91.3% with omeprazole 20 mg; there were no significant differences between two groups (p=0.9228). In per-protocol analysis, healing rates of revaprazan 200 mg and omeprazole 20 mg were 94.4% and 92.3%, respectively. There was no significant difference in healing rate between two groups (p=0.5666). There was no significant difference between two groups in improvement rates of daytime and nighttime pain. Both drugs were well tolerated. CONCLUSIONS: Revaprazan 200 mg was equivalent to omeprazole 20 mg for both ulcer healing and symptom relief, and was well tolerated in patients with duodenal ulcer.

Preoperative Chemotherapy in Gastric Cancer

Gastric cancer is the most prevalent cancer in Korea and comprises the second cause of cancer death. Surgery only can provide chance of cure, but most locally advanced cancers recur after a curative resection, even though important advances in the surgical and nonsurgical treatments of gastric cancer have taken place. Preoperative chemotherapy theoretically can provide the advantages of reducing the bulk of tumor, which might improve the R0 resection rate, and of treating micrometastases early. Also, preoperative chemotherapy is expected to render unresectable tumors resectable without increasing postoperative morbidity and mortality. There are many new chemotherapeutic agents available for the treatment of advanced gastric cancer, but still the most effective agent, the optimal time and number of cycle for administration are still not known. The addition of postoperative chemotherapy through an intraperitoneal route and/or radiotherapy might affect the outcome of surgery favorably, but that hasn't been proved yet. A multicenter prospective randomized phase III trial should be performed to answer for those questions and to improve the curability of gastric cancer treatment.

A Phase III Clinical Trial of Stillen(TM) for Erosive Gastritis / 대한소화기내시경학회지

BACKGROUND/AIMS: Phase IIb clinical study of Stillen(TM), a novel cytoprotectant, for gastritis showed 180 mg of Stillen, t.i.d. for 2 weeks results in a significant increase of cure rate when compared with a placebo group. It is reported that antioxidative effect and strengthening the endogenous cytoprotective molecules of the gastric mucosa play a pivotal role for cytoprotective action of Stillen(TM). The aim of this phase III multicenter, double-blind comparative study was to assess the efficacy of Stillen(TM) for the treatment of erosive gastritis. METHODS: Five hundred and twelve patients with erosive gastritis were enrolled and divided into three groups. Each group received 180 mg or 360 mg of Stillen(TM) or 600 mg of cetraxate (Neuer(TM)) t.i.d. for 2 weeks, respectively and a follow-up endoscopic examination for evaluation. RESULTS: Patients treated with 180 mg and 360 mg of Stillen(TM) had a significantly improved endoscopic cure rate of gastritis (55.6% and 57.5%, respectively) compared with patients treated with 600 mg of cetraxate (35.5%, p<0.001). Endoscopic improvement rate was also significantly higher in 180 mg group (67.3%) and 360 mg group (65.0%) of Stillen(TM) treated patients than cetraxate treated group (46.4%, p<0.001). During the study, both Stillen(TM) and cetraxate were well tolerated. CONCLUSIONS: These results clearly demonstrate that Stillen(TM) is an efficacious, safe, and well-tolerated treatment for gastritis.

Optimal Scheme of Postoperative Chemoradiotherapy in Rectal Cancer: Phase III Prospective Randomized Trial / 대한방사선종양학회지

PURPOSE: To determine the optimal scheme of postoperative chemoradiotherapy in rectal cancer by comparing survival, patterns of failure, toxicities in early and late radiotherapy groups using a phase III randomized prospective clinical trial. MATERIALS AND METHODS: From January 1996 to March 1999, 307 patients with curatively resected AJCC stage II and III rectal cancer were assigned randomly to an 'early (151 patients, arm I)' or a 'late (156 patients, arm II)' and were administered combined chemotherapy (5-FU 375 mg/m2/day, leucovorin 20 mg/ m2, IV bolus daily, for 3 days with RT, 5 days without RT, 8 cycles with 4 weeks interval) and radiation therapy (whole pelvis with 45 Gy/25 fractions/5 weeks). Patients of arm I received radiation therapy from day 1 of the first cycle of chemotherapy and those of arm II from day 57 with a third cycle of chemotherapy. The median follow-up period of living patients was 40 months. RESULTS: Of the 307 patients enrolled, fifty patients did not receive scheduled radiation therapy or chemotherapy. The overall survival rate and disease free survival rate at 5 years were 78.3% and 68.7% in arm I, and 78.4% and 67.5% in arm II. The local recurrence rate was 6.6% and 6.4% ( p=0.46) in arms I and II, respectively, no significant difference was observed between the distant metastasis rates of the two arms (23.8% and 29.5%, p=0.16). During radiation therapy, grade 3 diarrhea or more, by the NCI common toxicity criteria, was observed in 63.0% and 58.2% of the respective arms ( p=N.S.), but most were controlled with supportive care. Hematologic toxicity (leukopenia) greater than RTOG grade 2 was found in only 1.3% and 2.6% of patients in each respective arm. CONCLUSION: There was no significant difference in survival, patterns of failure or toxicities between the early and late radiation therapy arms. Postoperative adjuvant chemoradiation was found to be a relatively safe treatment but higher compliance is needed.

A Prospective Randomized Trial Comparing the Sequence of Adjuvant Chemotherapy and Radiotherapy following Curative Resection of Stage II, III Rectal Cancer / 대한방사선종양학회지

PURPOSE: To evaluate the side effects, pattern of failure, and survival rate according to the sequence of postoperative adjuvant radiotherapy and chemotherapy, patients with stages II and lll rectal cancer who had undergone curative resection were randomized to early radiotherapy group (arm I) or 'late radiotherapy group (arm II)', then we intend to determine the most effective sequence of the radiotherapy and chemotherapy. MATERIALS AND METHODS: From January 1996 to March 1999, 3 13 patients with curatively resected stages II and III rectal cancer have been randomized to early' or late radiation therapy group and recei ved combined chemotherapy (5-FU 375 mg/m/day, leucovorin 20 mg/m, IV bolus daily D1-5, 8 cycles) and radiation therapy (whole pelvis with 45 Gy/25 fractions/5 weeks). Arm I received radiation therapy from day 1 with first cycle of chemotherapy and arm II received radiation therapy from day 57 with third cycle of chemotherapy after completion of first two cycles. Preliminary analysis was performed with 228 patients registered up to Jun 1998. Two out of the 228 patients were excluded because of double primary cancer. Median follow-up period was 23 months. RESULTS: Local recurrence occurred in 11 patients (9.7%) for arm I and 9 patients (8%) for arm II. There was no significant difference between both groups (p=0.64). However, distant metastasis was found in 22 patients (19.5%) for arm I and 35 patients (31.0%) for arm II and which showed statistically significant difference between the two groups (p=0.046). And neither 3-year disease-free survival (70.2% vs 59.2%, p=0.2) nor overall survival (89.4% vs 88.0%, p=0.47) showed significant differences. The incidence of leukopenia during radiation therapy and chemotherapy was 78.3% and 79.9% respectively but leukopenia more than RTOG grade 3 was only 2.1% and 6.0% respectively. The incidence of diarrhea more than 10 times per day was significantly higher in the patients for arm I than for arm II (71.2% vs 4 1.6%, p=0.02) but this complication was controlled with supportive cares. CONCLUSION: Regardless of the sequence of postoperative adjuvant radiation therapy and chemotherapy a fter curative resection for rectal cancer, local recurrence rate was low with combined chemoradiotherapy. But distant metastasis rate was lower in early radiation therapy group than in late radiation therapy group and the reason is unclear. Most patients completed these treatments without severe complication, so these were thought to be safe treatments but the treatment compliance should be improved.