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LiFE re
Literature for ENYGO
Medical treatment of primary or recurrent cervical cancer
Editor Kristina Lindemann
Descriptive summary
Salihi et al. published a retrospective study on the feasibility of
neoadjuvant chemotherapy followed by fertility sparing surgery for
early cervical cancer. The objective was to study clinical outcomes
after NACT followed by conization. The hypothesis being that radical
trachelectomy still comes with increased risk of premature labour
and considerable postoperative morbidity and may be avoidable in a
selected subset of patients. Eleven patients were included, 10 with
1B1 and 1 with IB2 disease (refused radical treatment upfront). All
patients underwent pelvic lymphadenectomy prior to NACT to ensure
that only node-negative patients were included. 64 % of the patients
had tumours <2cm. Patients were mainly treated with carboplatin/
taxol in different dosing schedules. RECIST criteria showed complete
response in 3 patients (64 %), partial response in three (27 %) and
one patient (9 %) had progressive disease. 8 patients had complete
pathological remission. Of the 9 patients treated with fertility-spar-
ing (81 %), 6 got pregnant and 5 delivered a total of 7 babies (2 born
prematurely). There was 1 recurrence after median 58 months. This
study described the feasibility of this approach, but has its limita-
tions in its retrospective design and small sample size. The funding
of one large randomised trial on NACT+fertility sparing surgery is
unfortunately still uncertain.
Tewari et al. published a prospective validation of a prognostic score
in the GOG 240 study (4 arms, Taxol/Cis or Taxol/Topotecan +/- Bev).
The “Moore criteria” combined five factors: Performance status >0,
pelvic disease, African-American ancestry, disease-free interval <1
year, and prior platinum exposure. The risk score was tested in multi-
ple subsets (by treatment arm), but only few significant differences
could be found between the low-risk and high-risk group. Patients
categorised as low-risk derived only non-significant benefits from
the addition of Bev in terms of PFS. However, only 84 of the patients
fell into this category. The authors suggest that in light of the
toxicity associated with Bev, one could argue against the use of Bev
in the low-risk group where potential benefit may be small. However,
if risk (i.e., of fistula) differs remains uncertain, as toxicity was not
specifically reported by risk group. Furthermore, it is not clear if the
study was powered to detect any differences in subgroups, but the
discussion of the results does unfortunately not cover its limitations.
Questions remain regarding the applicability of the score to popula-
tions with a lower prevalence of African-Americans and if that factor
is a surrogate for poorer access to health care services or represents
true biological differences.
Continued on the next page 
International Journal of Gynecological Cancer, Volume 26, Supplement #1
CERVICAL CANCER
Marnitz et al. reported on a randomized trial on surgical vs. clinical
staging followed by chemoradiation in patients with stage IIB-IVA
disease (Uterus-11). Here, effects on toxicity and treatment quality
are reported. 255 patients were randomised. It is unfortunately
unclear how ITT, safety population, and per-protocol population were
defined. Chemotherapy regimen differed significantly between the
treatment arms. More patients in the surgical staging arm received
extended field radiation, confirming that more patients are upstaged
by surgery. There was generally more haematological but less
non-haematological toxicity after IMRT. This is expected as IMRT is
associated with a higher volume of bone marrow covered by lower
doses. One interesting issue discussed in these articles, although
not the primary outcome of the trial itself, is the quality indicators of
radiotherapy. For the US, only 25 % of centres have been reported to
meet certain quality benchmarks (the use of BT, >4 cycles of chemo-
therapy, and a RT duration of 56 days) (Smith et al. Int J Radiat Oncol
Biol Phys 2015;92:260-267). In the presented study, median duration
was 55 days, 98 % and 94 % had received BT and, at least in the
clinical staging arm, >80 % of the patients had received >4 cycles of
CT, confirming that the study met all quality indicators for chemora-
diation. The oncological outcomes are not yet mature.
Xie et al. published a prospective study on the value of aldehyde
hydrogenase 1 (ALDH 1) in predicting response to NACT. ALDH 1
has been reported to be a marker of stem cell proliferation. Patients
with positive staining of the tumour tissue were less likely to
respond to NACT and post-NACT ALDH 1 expression was associated
with poorer survival outcomes. Unfortunately, it is not stated if the
assessment of staining was performed blinded for clinical outcomes.
Also, the RECIST criteria used for response do not correspond to the
standard interpretation of RECIST. Differences in survival data were
only assessed by a log-rank test, but median survival times with con-
fidence intervals are not given. Also, postoperative treatment may
have varied between the groups and is not adequately described.
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