A Nationwide Cohort Study of Surveillance for Stage I Seminoma

Reporter: J Taylor Whaley, MD
The Abramson Cancer Center of the University of Pennsylvania
Ultima Vez Modificado: 3 de junio del 2013

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Presenter: Mette Sakso Mortensen, MD
Presenter's Affiliation: Copenhagen University Hospital, Copenhagen, Denmark
Abstract #: 4502

Background

  • Seminoma is the most common tumor in young men aged 15-35, but it is fortunately also one of the most treatable and curable cancers with greater than 95% survival.
  • Stage I is the most common presentation for seminoma, accounting for more than 80% of all seminomas.
  • The standard treatment for stage I seminoma involves surgical resection of the involved testis; however, adjuvant therapy following surgery remains a topic for discussion. Options include radiation to the para-aortic nodes, carboplatin, or active surveillance.
  • Survival rates for stage I seminoma are excellent irrespective of treatment modality (radiation, carboplatin, or surveillance). Carboplatin and radiation result in less risk of recurrent disease, but cause acute side effects with potential late effects, including second cancers and decreased fertility.
  • Although active surveillance is associated with an increased risk of recurrence, the vast majority of patients will be salvageable at the time of recurrence. This approach can allow more than 80% of patients to avoid chemotherapy and/or radiation.
  • A review of the current literature demonstrates the risk of recurrence for stage I patients without adjuvant therapy is approximately ~15%.
  • For patients that do have recurrence, salvage therapy is very effective, with cancer specific survival remaining >99%.
  • With such excellent cure rates, the focus of therapy has evolved into maximizing quality of life by minimizing toxicity while maintaining exceptional outcomes.
  • The authors present data from a large nationwide cohort study on surveillance in stage I seminoma patients.

Materials and Methods

  • Utilizing the Danish nationwide and population based clinical database covering germ cell cancer patients diagnosed 1984-2008, the authors evaluated 4,683 cases.
  • All stage I seminoma patients followed by surveillance were identified.
  • All patients were greater than 15 years old.
  • No patients had synchronous testicular cancers
  • Possible prognostic factors for relapse, including tumor markers and pathologic findings, were collected from patient files and pathology reports.
  • The authors utilized Danish National Registry using hospital in-patient visits to collect data on late relapses and the Danish Registry for death to identify cause of death on all patients

Results

  • 1,822 patients with stage I seminoma were followed on a surveillance program.
  • The median follow-up time was 15.4 years.
  • Median age of patients at diagnosis was 36.7 years (Range 16-82).
  • Ten year cancer specific survival (CSS) was 99.6%.
  • A total of 355 (19.5%) patients had a relapse after a median time of 13.7 months (range 1.2-173.7 months).
  • Within 2-5 years after orchiectomy, 72 patients (4.0 %) had a relapse and 26 patients (1.4 %) had a relapse more than 5 years after orchiectomy.

Time to Recurrence

Time to Relapse Number of Relapses

0-24 months

257 (14%)

24-60 months

72 (4%)

>60 months

26 (1.4%)

Multivariate Analysis

Risk Factor

Hazard Ratio

Statistical Value

Hcg > 200 units/L

3.58

Significant Difference

Invasion of Small Vessels

1.37

Significant Difference

Tumor > 4 cm

1.39

Significant Difference

Invasion of Rete Testes

1.13

No Significance

Invasion of Epididymus

1.3

No Significance

  • The outcomes can be seen in the table above.
  • Invasion of blood or lymphatic vessels, tumor size >4 cm and serum human chorionic gonadotropin. 200 IU/L were all predictive factors for relapse in both univariate and multivariate analyses.
  • Invasion of rete testis was significant in the univariate analysis but not in the multivariate analyses.
  • 70% of relapses were stage IIA or IIB, indicating the ability to salvage successfully with radiation.
  • All but 2 recurrences were in the good prognostic group in the risk stratification for testicular germ cell tumors.
  • Of the 26 patients with late recurrences, 3 patients died while 18 patients have no evidence of disease
  • As part of their salvage treatment, 216 patients received radiation while 163 received chemotherapy.
  • The authors also reported their proposed follow up schedule for patients with stage I seminoma. This follow up schedule included 5 total CT scans (every 6 months for 2 years and a final scan at 5 years) and tumor markers and physical exam (every 2 months for one year, every 3 months for the 2nd year, and every 6 months for years 3-5).

Author's Conclusions

  • The authors present the largest cohort ever published of stage I seminoma patients followed on a surveillance program.
  • The prognosis was excellent with a 10 year cancer specific survival of 99.6%. Prognostic factors for relapse, including Hcg > 200 units/L, invasion of small vessels, and tumors >4 cm, were identified on multivariate analysis.
  • Most recurrences occurred within 2 years, and the relapse rate after 5-years of follow-up was 1.4%.
  • Active surveillance for stage I seminoma is safe and should be the preferred option of management in stage I seminoma patients as it avoids unnecessary treatment for 80% of patients.

Clinical Implications

  • The authors presented a large nationwide cohort study evaluating the use of active surveillance for stage I seminoma following orchiectomy. This is an area of much interest for today's oncologists.
  • Because current outcomes with stage I seminoma are very good, there is considerable focus on decreasing treatment toxicity and de-escalating therapy. Both adjuvant radiation and chemotherapy have potential acute and late toxicity, increasing interest in active surveillance. Additionally, adjuvant therapy may be safely omitted in approximately 80% of patients.
  • The outcomes in this study are similar to that seen in other smaller studies with 15-20% recurrence rates and >95% cause specific survival.
  • However, active surveillance has other challenges, including the stress associated with risk of recurrences as well as poor compliance with surveillance imaging that has been documented. For this reason, patient compliance with follow up and imaging is a requirement for surveillance to work effectively.
  • Active surveillance is the emerging standard of care in stage I seminoma for compliant patients.
  • Additional future studies should continue to identify particular patient populations at risk for recurrence to decrease the number of patients that need to undergo salvage therapy.
  • Other areas of future research may include focus on identifying patient groups who are good candidates for close surveillance within specific cultural and economic environments, as patients lost to follow-up during planned active surveillance may be at increased risk of dying from this very curable disease.



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