Real-world effectiveness and safety of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C: AMBER study.

BACKGROUND: Virologic and safety outcomes of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin (OBV/PTV/r ± DSV ± RBV) therapy have shown high sustained virologic response (SVR) rates and good tolerability in most patient populations in pre-registration studies. AIM: To confirm these clinical trial findings in the treatment of genotype 1 and 4 hepatitis C under real-world conditions. METHODS: Patients enrolled for treatment with OBV/PTV/r ± DSV ± RBV based on therapeutic guidelines were included, and the regimen was administered according to product characteristics. Clinical and laboratory data, including virologic response, were collected at baseline, end of treatment (EOT) and 12 weeks after EOT. RESULTS: A total of 209 patients with chronic hepatitis C were enrolled, most were genotype 1b-infected (84.2%) and 119 (56.9%) had liver cirrhosis. Among these, 150 (71.7%) had failed previous anti-viral therapies and 84 (40.2%) were null-responders. At 12 weeks after EOT, SVR was achieved by 207 (99.0%) patients, ranging from 96.4% to 100.0% across subgroups. All Child-Pugh B and post-orthotopic liver transplantation patients achieved SVR. Adverse events occurred in 151 (72.2%) patients and were mostly mild and associated with the use of RBV. Serious adverse events, including hepatic decompensation, renal insufficiency, anaemia, hepatotoxicity and diarrhoea, were reported in eight (3.8%) patients. In five (2.4%) patients, adverse events led to treatment discontinuation. On-treatment decompensation was experienced by seven (3.3%) patients. CONCLUSIONS: The results of our study confirm previous findings. They demonstrate excellent effectiveness and a good safety profile of OBV/PTV/r± DSV±RBV in HCV genotype 1-infected patients treated in the real-world setting.

[Sperm, LH FSH, testosterone evaluation in patients with testicular cancer. Preliminary study]. / Ocena wybranych parametrów nasienia i poziomów hormonów FSH, LH, testosteronu u chorych na raka jadra. Doniesienie wstepne.

In the last 20 years the treatment results of testicular cancer has been improved. At the present time up to 90% of patients are cured. Following successful treatment young men want to assess their fertility and possibility to have children. 18 men with testicular cancer has been treated in Institute of Oncology in Warsaw. Before and/or after orchidectomy semen analysis and assessment of serum levels of FSH, LH, testosterone has been performed. The quality of the semen is much worse in the group with cancer compared to healthy controls. Semen analysis following orchidectomy revealed that spermatozoa count did not change, FSH, LH levels increased and testosterone level decreased.

[Sigmoid-vesical fistula as a consequence of sigmoid tumor]. / Przetoka esiczo-pecherzowa w nastepstwie raka esicy.

Because of unusual rarity of neoplastic sigmoid-vesical fistula in young patients the case of 43 years old woman, in whom the fistula was the consequence of sigmoid adenocarcinoma infiltration of urinary bladder, was presented. The patient was treated radically by resection of the sigmoid and partial resection of the urinary bladder within healthy tissue. After operation the patient was exposed to radiotherapy, after which chemotherapy followed (6 courses of 5-day chemotherapy with fluorouracil and calcium folinate). 18 months after operation, 16 months after radiotherapy and 14 after chemotherapy patient's general condition was good and control laboratory tests did not indicate the relapse of the neoplasm.

A report comparing the use of tropisetron (Navoban), a 5-HT3 antagonist, with a standard antiemetic regimen of dexamethasone and metoclopramide in cisplatin-treated patients under conditions of severe emesis.

This report of a double-blind, randomized study performed to evaluate the comparative antiemetic efficacy of tropisetron (Navoban; Sandoz Pharma Ltd, Basel, Switzerland), a new 5-hydroxytryptamine receptor antagonist, focuses on treatment during stages of chemotherapy when nausea and vomiting are particularly severe. One hundred fifteen chemotherapy-naive patients with malignant disease were administered either tropisetron (n = 58) or a dexamethasone dose plus a metoclopramide dose (n = 57) during 5 days of two successive cycles of chemotherapy. Within the first 24 hours after receiving cisplatin-based chemotherapy, 76% of patients in the tropisetron group remained free of vomiting (with 59% of patients free of nausea) compared with 39% of patients free of vomiting in the conventionally treated group (30% of patients free of nausea). Improved control of emesis also was observed over 4 consecutive days of follow-up in the tropisetron group. The difference in incidence of nausea and vomiting between the patient groups was statistically significant (P < .05). The efficacy of tropisetron was well maintained during the second consecutive chemotherapy cycle; during the first 24 hours, 72% and 62% of patients remained free of vomiting and nausea, respectively. Tropisetron appears to be a highly effective, well tolerated, and simple to use antiemetic agent for patients receiving chemotherapy.

[Evaluation of the results of combined treatment of patients with testicular seminoma in the II stage of clinical advancement]. / Ocena wyników skojarzonego leczenia chorych na nasieniaki jadra w II stopniu zaawansowania klinicznego.

An attempt to introduce combined therapy for patients with testicular seminoma in the II degree of clinical advancement was undertaken at the Centre of Oncology. Combined therapy consisted of 3 courses of PVB in the following daily doses: DDP 100 mg/m2 i.v. on the first day; VLB 10 mg i.v. on the first and second day; bleomycin 30 mg i.v. on the second, ninth and sixteenth day every 21 days, and 60Co on lymphatic glands area in which metastases were diagnosed prior to chemotherapy. Twenty three patients were treated that way between January 1985 and June 1989. Mean follow-up period after the treatment was 14 months. One patient died for the tumor, metastases to the lungs were diagnosed in one patient 9 months after completion of the treatment which ameliorated after "second" chemotherapy, and 22 patients (96%) are still free from the symptoms of active disease.

Risk-related adjuvant chemotherapy for stage I non-seminoma of the testis.

Seventy-Two patients with stage I testicular non-seminoma presenting between January 1984 and December 1988 were managed either by adjuvant chemotherapy in the presence of histological adverse prognostic factors or by surveillance if none of these factors were present. The determining factors were vascular invasion, lymphatic invasion, involvement of the epididymis, involvement of the rete testis. Thirty patients were treated with three courses of platinum, vinblastine and bleomycin (PVB) and 42 were managed by surveillance. All 72 patients are alive and have been free of disease from 12-60+ months. One of 42 patients managed by surveillance relapsed 16 months after orchidectomy and he has been disease-free for 32+ months after chemotherapy. No relapses occurred in patients treated with adjuvant chemotherapy. The results confirm the suggestion by Peckham (Hoskin et al., 1986) that histopathological analysis of the primary tumour can provide the basis for subsequent management either by surveillance or chemotherapy.

[Evaluation of selected prognostic factors in planning of the treatment of patients with stage I testicular non-seminoma]. / Ocena wybranych czynników prognostycznych w planowaniu leczenia chorych na nienasieniaki jadra w I stopniu zaawansowania.

The choice of treatment in 72 patients with non-seminomas of the testis in the 1st stage of clinical advancement after orchidectomy has been in the Oncology Center in Warsaw made in connection with factors assessed on microscopic examination of resected testis as prognostically important (infiltration of the tunica albuginea, epididymis and testicular cord, cellular cancer embolisms of blood and lymphatic vessels). In 30 (out of 72) patients with such factors three courses of chemotherapy according to the PVB programme have been applied. 42 (out of 72) patients without such factors have been under observation. All patients are alive. In one patient of the 42 group observed without treatment progression of the disease has been noted on 16th month of the follow up and the treatment according to PVB programme has been applied with complete regression (CR) as result; patient is alive without symptoms of the active disease 28 months since the completion of the treatment. The probability of 48 months survival, calculated according to life tables is 96%.

[Preliminary evaluation of prognostic factors in selecting the methods of treatment of patients with stage I testicular seminoma]. / Wstepna ocena czynników rokowniczych w wyborze metody leczenia chorych na nasieniaka jadra w I stopniu zaawansowania.

The management of 50 patients with seminomas in 1st stage of the clinical advancement after orchidectomy in the Oncology Center in Warsaw in the period since January 1984 until June 1989 depended on the presence of high risk factors (the infiltration of the tunica albuginea of the testis of the epididymis and/or testicular cord, and the presence of cellular cancer embolisms in the blood or lymphatic vessels). In 11 (out of 50) patients in which such factors have been present three courses of chemotherapy according to PVB programme have been applied (DDP-80 mg/m. sq. i.v. (on the 1st day; VLB-10 mg, i.v., day 1-2, BLM-30 mg i.v., 2nd, 9th and 16th day, 21 days rhythm). The remaining group of 39 patients without microscopic factors have been observed without treatment ("wait and watch policy"). During the follow up of 17 patients receiving PVB (mean 17 months) in no one case the progression of the disease have been noticed. In 2 (out of 39) patients observed without treatment in 6th and 8th month correspondingly, the progression of the disease has been found and chemotherapy according to PVB programme applied with subsequent irradiation of the regional lymphatic system, with complete remission as result. Both patients are alive for 14 and 16 months correspondingly without active disease.

Early results on modification of combined modality treatment (chemotherapy and surgery) for testicular cancer.

Early results of modified combined modality of treatment (chemotherapy and surgery) of 58 patients with nonseminoma of the testis treated in the Institute of Oncology in Warsaw from January 1983 to December 1985 indicated a significant improvement in comparison to the preceding period of time (70 vs. 80% probability of 5-year survival). The treatment was well tolerated and no patient refused therapy. The authors suggest that this improvement can depend on using a more effective program of chemotherapy in half the patients (VAB-6) and the majority of less advanced treated cases than in the last period. This problem will be the subject of further investigation.

Clinical usefulness of serum ferritin measurements in patients with testicular germ cell tumors.

In 50 patients with seminoma and in 50 with nonseminomatous germ cell tumors of the testis, serum levels of conventional markers (CEA, AFP, hCG) and ferritin were measured at the time of admission and during management. The conventional markers behaved as reported previously. After orchiectomy, elevated levels of ferritin were found in the presence as well as in the absence of tumor; the extent of these elevations was highly variable. Serial determinations of serum ferritin showed two patterns of variation. First, in patients treated with retroperitoneal lymph node dissection, irradiation, and chemotherapy regimens without platinum, decreasing levels of the conventional markers and serum ferritin were associated with response to therapy and increasing levels with relapse of tumor. Second, in patients treated with chemotherapy regimens containing cis-diamminedichloroplatinum, the conventional markers returned to normal values while the ferritin level doubled or tripled and returned to pretreatment or normal values only several weeks after therapy. Thus, it appears that hyperferritinemia was a sensitive index of platinum toxicity. We conclude that the serum ferritin level has no value in staging after orchiectomy but is a useful index of response to therapy during treatment with retroperitoneal lymph node dissection, irradiation or chemotherapy without platinum or relapse of tumor. During treatment with platinum, elevated levels might be explained as a possible toxic side effect of this drug.