Phase II Study: Adjuvant Single-Agent Carboplatin Therapy for Clinical Stage I Seminoma

Krege, Susanne; Kalund, G.; Otto, T.; Goepel, Μ.; Rübben, H.

doi:10.1159/000474497

Cited by 63 publications

(22 citation statements)

References 12 publications

(14 reference statements)

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“…Several small pilot studies demonstrated low relapse rates in the range of 3 -5% using 1 -2 courses of carboplatin (Oliver and Ong, 1996;Krege et al, 1997;Dieckmann et al, 2000). The potential advantage of this treatment option may be the reduced treatment time, treatment of micrometastasis outside the strictly defined portals of radiotherapy, reduction in the risk of secondary malignancies, and improvements in treatment-related toxicities.…”

Section: Discussionmentioning

confidence: 99%

Para-aortic irradiation for stage I testicular seminoma: results of a prospective study in 675 patients. A trial of the German testicular cancer study group (GTCSG)

et al. 2004

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A prospective nonrandomised trial was performed in order to evaluate tumour control and toxicity of low-dose adjuvant radiotherapy in stage I seminoma with treatment portals confined to the para-aortic lymph nodes. Between April 1991 and March 1994, 721 patients were enrolled for the trial by 48 centres in Germany. Patients with pure seminoma and no evidence of lymph node involvement or distant metastases received 26 Gy prophylactic limited para-aortic radiotherapy. Disease-free survival at 5 years was the primary end point. With a median follow-up of 61 months, 675 patients with follow-up investigations were evaluable for this analysis. Kaplan -Meier estimates of disease-free and disease-specific survival were 95.8% (95% CI: 94.2 -97.4) and 99.6% (95% CI: 99.2 -100%) at 5 years and 94.9% (95% CI: 92.5 -97.4%) and 99.6% (95% CI: 99.2 -100%) at 8 years, respectively. A total of 26 patients relapsed. All except two were salvaged from relapse. In all, 21 recurrences were located in infradiaphragmatic lymph nodes without any 'in-field' relapse. Nausea and diarrhoea grade 3 were observed in 4.0 and 1.0% of the patients, respectively. Grade 3 late effects have not been observed so far. The results of our trial lend further support to the concept of limited para-aortic irradiation as the recently defined new standard of radiotherapy in stage I seminoma. There is no obvious compromise in disease-specific or disease-free survival compared to more extensive hockey-stick portals, which were used as standard portals at the time this study was initiated.

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Section: Discussionmentioning

confidence: 99%

Para-aortic irradiation for stage I testicular seminoma: results of a prospective study in 675 patients. A trial of the German testicular cancer study group (GTCSG)

et al. 2004

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“…[9][10][11][12][13][14][15][16][17][18][19][20][21][22][23][24][25][26][27] Three were randomized controlled trials, 9 were phase 2 trials, and 5 were from prospective institutional databases. For purposes of summary data generation, these studies included a total of 5561 patients ( Table 2).…”

Section: Study Characteristicsmentioning

confidence: 99%

Evidence‐based guidelines for following stage 1 seminoma

Martin

Panzarella

Zwahlen

et al. 2007

Cancer

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A chemically crosslinked biodegradable hydrogel was prepared via a macromer technique, and physicochemical characterizations associated with its potential application as an injectable biomaterial were carried out. The macromers were composed of poly(ethylene glycol) extended with oligomers of biodegradable polyesters such as oligolactide and end‐capped with acryloyl groups. Hydrogels were obtained through the polymerization of the macromer aqueous solutions in phosphate‐buffered saline initiated by a redox initiator system at body temperature. The initiator system was composed of ammonium persulfate as an initiator and N,N,N′,N′‐tetramethylethylene diamine as an accelerator. The modulus of this chemical gel was much higher than that of a Pluronic physical gel. In vitro biodegradation was also confirmed. The degradation rates were highly tunable by the adjustment of several factors, such as the kind of ester group, the block length of the oligoester, and even the concentration of the accelerator used in the crosslinking reaction. The gelation time could be adjusted to meet the requirements of an injectable biomaterial. The effect of the polymerization heat seemed not to be significant. This kind of biodegradable hydrogel might be in situ formed after being injected into the body and shows potential applications as a unique tissue engineering material free of porogening techniques in scaffold fabrication and less invasive in implantation. © 2005 Wiley Periodicals, Inc. J Appl Polym Sci, 2006

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“…Consequently, any purported advantage of adjuvant chemotherapy over surveillance must be seriously questioned -especially as the risk of relapse in the paraaortic and pelvic lymph nodes is reduced by only 10% (from 15 to 5%). Data from other series indicate that, if adjuvant carboplatin is given in this setting, then 2 courses of treatment are necessary [21][22][23][24][25][26]. However, even with 2 cycles of carboplatin, a small but significant percentage of patients recur in the retroperiteonum, and therefore continued surveillance of the retroperiteonal lymph nodes is necessary.…”

Section: Chemotherapymentioning

confidence: 99%

Treatment Options, Prognostic Factors and Selection of Treatment in Stage I Seminoma

2006

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Treatment options in patients with stage I seminoma include radiotherapy (RT), surveillance, and adjuvant chemotherapy. This patient population has virtually a 100% cure rate whichever approach is taken. While adjuvant retroperitoneal RT has been the standard of care for the past 50-60 years, there is increasingly persuasive data that adjuvant RT in this setting is associated with a small but definite increased risk of second malignancy and cardiovascular death. The long-term data from surveillance series have documented the safety of this approach, and it is now accepted that a policy of surveillance is the optimal management approach. This gives a relapse rate of 15%, and most patients can be successfully salvaged with RT. Second relapse after salvage RT occurs in a small proportion of cases, and these patients are cured with chemotherapy. Adjuvant chemotherapy using carboplatin has been investigated as an alternative strategy but has not lived up to its initial promise. If used, then 2 courses of treatment should probably be given. It must be remembered that 80-85% of patients with testicular seminoma require no treatment after orchiectomy, and the long-term side effects of any adjuvant treatment approach must be carefully considered.

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Phase II Study: Adjuvant Single-Agent Carboplatin Therapy for Clinical Stage I Seminoma

Cited by 63 publications

References 12 publications

Para-aortic irradiation for stage I testicular seminoma: results of a prospective study in 675 patients. A trial of the German testicular cancer study group (GTCSG)

Para-aortic irradiation for stage I testicular seminoma: results of a prospective study in 675 patients. A trial of the German testicular cancer study group (GTCSG)

Evidence‐based guidelines for following stage 1 seminoma

Treatment Options, Prognostic Factors and Selection of Treatment in Stage I Seminoma

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