LANDONI Study
Randomized study of radical surgery versus radiotherapy for stage Ib-IIa cervical cancer

Disease site

Cervix

Pubmed link

https://pubmed.ncbi.nlm.nih.gov/9284774/

Publication month/year

August 1997

Study question

To compare the efficacy of radial surgery with pelvic radiation for the treatment of newly diagnosed stage Ib -IIa cervical cancer

Type of study

Randomised controlled trial (RCT)

Interventions compared

Radical surgery vs pelvic radiation

Experimental arm (Intervention)

Class III radical abdominal hysterectomy with pelvic lymph node dissection  

*Adjuvant radiotherapy was given if: *

  • Surgical stage > pT2a
  • Lymph node metastasis 
  • <3 mm of disease- free cervical stroma
Control arm

External pelvic irradiation using 18 MV photon beam

Primary outcome
  • 5-year survival 
  • Rate of complications
Secondary outcome
  • Recurrence
Inclusion criteria
  • Age 30-70 years
  • Newly diagnosed cases of cervical cancer 
  • FIGO stage Ib – IIa 
  • WHO performance status of 1 or less
Exclusion criteria

Concurrent or history of malignancy

Results
Intervention arm Control arm
Randomised (n)
169
158
Received treatment
Radical surgery and pelvic lymph node dissection
Radiotherapy
Overall 5-year survival
80%
82%
5-year survival if cervical diameter ≤4
87%
90%
5-year survival if cervical diameter >4
70%
72%
Recurrence rate (%)
25%
26%
Other Results

Complications in intervention arm :

  • Severe (grade 2-3): 48 (28%) 
  • Hydroureteronephrosis: 2 (3%) 
  • Chronic neurological bladder: 8 (13%)
  • Severe lower limb edema: none

Complications in Control arm: 

  • Severe (grade 2-3): 19 (12%)
  • Hydroureteronephrosis: 8 (5%) 
  • Chronic neurological bladder 
  • Severe lower limb edema: 1 (0.6%)

Complications in patients receiving surgery plus radiotherapy:

  • Hydroureteronephrosis: 11 (10%)
  • Chronic neurological bladder 5 (5%)
  • Severe lower limb edema: 10 (9%)

(11) patients died due to cervical cancer 

(2) patients died of complications: bowel perforation and pulmonary embolism (Both deaths occurred in the surgery group)

Conclusions

The study yielded no significant difference in the efficacy of either treatment modality. Thus, optimal therapy should take into consideration the clinical status of each individual. Moreover, the combination of radiotherapy and surgery resulted in the highest number of complications.

Study limitations

The data showed a discrepancy in the efficacy of radiotherapy in comparison with surgery for adenocarcinoma of the cervix, thus, histological types should be taken into consideration during the sample selection.

Reviewer name

Zeinab Obeid