Evidence map›Paper›PMID 39028943›Full record

Trial reportCancer research communications2024

Clinical Efficacy of the HIV Protease Inhibitor Indinavir in Combination with Chemotherapy for Advanced Classic Kaposi Sarcoma Treatment: A Single-Arm, Phase II Trial in the Elderly.

Cecilia Sgadari, Biancamaria Scoppio, Orietta Picconi, Antonella Tripiciano, Francesca Maria Gaiani, Vittorio Francavilla, Angela Arancio, Massimo Campagna, Clelia Palladino, Sonia Moretti and 3 more

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in Cancer research communications, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Cecilia SgadariNational HIV/AIDS Research Center, Istituto Superiore di Sanità, Rome, Italy.ORCID 0000-0003-0364-4912
Biancamaria ScoppioDermatology Unit, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan, Italy.ORCID 0009-0009-9354-9070
Orietta PicconiNational HIV/AIDS Research Center, Istituto Superiore di Sanità, Rome, Italy.ORCID 0000-0003-3626-9952
Antonella TripicianoNational HIV/AIDS Research Center, Istituto Superiore di Sanità, Rome, Italy.ORCID 0000-0001-7814-984X
Francesca Maria GaianiDermatology Unit, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan, Italy.ORCID 0009-0003-7613-4451
Vittorio FrancavillaNational HIV/AIDS Research Center, Istituto Superiore di Sanità, Rome, Italy.ORCID 0000-0003-1169-1188
Angela ArancioNational HIV/AIDS Research Center, Istituto Superiore di Sanità, Rome, Italy.ORCID 0000-0002-6747-0475
Massimo CampagnaNational HIV/AIDS Research Center, Istituto Superiore di Sanità, Rome, Italy.ORCID 0000-0002-8357-4530
Clelia PalladinoNational HIV/AIDS Research Center, Istituto Superiore di Sanità, Rome, Italy.ORCID 0000-0003-0740-5863
Sonia MorettiNational HIV/AIDS Research Center, Istituto Superiore di Sanità, Rome, Italy.ORCID 0000-0003-4812-1496
Paolo MoniniNational HIV/AIDS Research Center, Istituto Superiore di Sanità, Rome, Italy.ORCID 0000-0002-4941-6854
Lucia BrambillaDermatology Unit, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan, Italy.ORCID 0000-0001-9938-4427
Barbara EnsoliNational HIV/AIDS Research Center, Istituto Superiore di Sanità, Rome, Italy.ORCID 0000-0002-0545-8737

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Kaposi sarcoma is a rare angioproliferative disease associated with human herpes virus-8 (HHV-8) infection. Kaposi sarcoma is frequent and aggressive in HIV-infected people, whereas the classic form (CKS) generally has an indolent course. Notably, all conventional therapies against Kaposi sarcoma have only temporary efficacy. We have previously shown that indinavir, a HIV protease-inhibitor with direct antiangiogenic and antitumor activity, is safe and effective in patients with early CKS, whereas effects are less prominent in advanced disease, probably due to the larger tumor mass. Therefore, the clinical response to indinavir was assessed in patients with advanced CKS after debulking chemotherapy. This was a monocentric phase 2 trial in elderly with progressive/advanced CKS treated with debulking chemotherapy and indinavir combined, followed by a maintenance phase with indinavir alone. Secondary endpoints included safety and Kaposi sarcoma biomarker evaluation.All evaluable patients (22) responded to debulking therapy. Out of these, 16 entered the indinavir maintenance phase. The overall response rate at end of maintenance was 75% (estimated median response-duration 43 months). Moreover, most responders showed further clinical improvements (lesion number/nodularity) during maintenance and post-treatment follow-up. Notably, after relapse, progressors did not require systemic Kaposi sarcoma therapy and showed clinical improvements (including disease stabilization) remaining on study. Responders also showed immune status amelioration with a consistent B-cell increase and positive changes of other biomarkers, including anti-HHV-8 natural killer activity. In advanced CKS a strategy combining indinavir and chemotherapy is safe and associated with high and durable response rates and it could be rapidly adopted for the clinical management of these patients. SIGNIFICANCE: This phase-2 trial showed that the HIV protease inhibitor indinavir may boost and extend the duration of the effects of chemotherapy in elderly with advanced progressive classic Kaposi sarcoma, without additional toxicity. Further, the amelioration of the immune status seen in responders suggests a better control of HHV-8 infection and tumor-cell killing. Thus, indinavir combined with chemotherapy may represent an important tool for the clinical management of classic Kaposi sarcoma in elderly patients.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsHIV Protease InhibitorsIndinavirSarcoma, KaposiAgedAged, 80 and overFemaleHerpesvirus 8, HumanHumansMaleTreatment OutcomeHIV Protease InhibitorsIndinavir

Identifiers

PMID39028943
PMCPMC11324028

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.